Invitation to Supply. Part 5 - Statement of Requirements. Invitation to Supply Number: HPVITS Dental Consumables. Supply Name: HPVITS

Transcription

1 Invitation to Supply - Invitation to Supply Number: Invitation to Supply Name: Closing Date and time: 02 August :00 AEST Authorised Contact Person Jared Tang Category Manager Contact through the HPV Procurement Portal Published: 14 June 2016

2 Table of Contents Table of Contents A Introduction Purpose Scope Product Categories Product Conditions Definitions B Service, delivery, and support Delivery Urgent Deliveries Training Customer Service and Support Warranty Key Performance Indicators Reporting Service Level Agreement C General Requirements Standards and Compliance Packaging and Labelling Recall Process Backorders and Discontinued Lines Infection Control Superseded Products Shelf Life Reference Sites D Product Specifications Substances of Concern Instrument Trays Category Specifications Category 1 - Burs Burs, Diamond - Finishing and Polishing Burs, Diamond - Restorative Burs, Steel - Restorative Burs, Steel - Surgical Burs, Steel - Acrylic Stainless Steel Page 2 of 84

3 Table of Contents 1.06 Burs, Tungsten Carbide - Finishing and Polishing Burs, Tungsten Carbide - Restorative Burs, Tungsten Carbide - Surgical Bur Stands Mandrels Polishing Discs Category 2 - Endodontics Bleaching Material Broaches Barbed Broaches Smooth Cements and Sealers Drills Gates Glidden Drills - Peeso Drills Fillers and Spirals Files Hand Files - Pathfinders Files - Reamers Files - Rotary Fingers Pluggers and Spreaders Gauges and Rulers Irrigation - Solutions Medicaments Points - GP Points - Paper Post Endodontics Bleaching Products Rings and Stoppers Storage Accessories Temporary Filling Category 3 - General Consumables Air Water Syringe Tips Anaesthetics Needles Applicator, one-piece - Micro-Brushes Applicator, one-piece - Multi-Brushes Articulating - Papers Aspirator Tube - Disposable Barriers and Drapes Products Bibs Page 3 of 84

4 Table of Contents 3.09 Bib Chains Cotton Products Cotton Guards Cotton Products Cotton Haemostat and Pledgets Cotton Products Cotton Pellets Cotton Products Cotton Rolls Dappen Dishes Dental Impression Solutions - Disinfection Material Dental Water-Unit Treatment - Tablets Disposable Holders - Wells Distilled Water Gingival Retraction Cords Gingival Retraction Haemostatic Solutions Haemostatic Sponges Mixing Pad for Impression and Restorative Material Rubber Dam Sheets Rubber Dam Accessories - Interproximal Elastic Stabiliser Saliva Ejectors Suction Tube Adaptor Suction Tube Single Use Category 4 - Impression Products Bite Registration Silicone Bite Registration Wax Denture Pressure Indicator Paste Impression Adhesives Impression Dispensing Tools Impression Tray Cleaners Materials - Impression Addition Silicone Materials - Impression Alginate Materials - Impression Polyether Materials - Impression Polyvinyl Silaxane Materials - Impression Zinc Oxide Eugenol (ZOE) Spatulas Trays - Metal Trays - Single use, disposable Category 5 - Instruments and Accessories Amalgam Carriers Applicator Instruments Page 4 of 84

5 Table of Contents 5.03 Articulating Paper Holder Aspirating Syringes Composite Gun Composite Instruments Cord Packers Crimping Pliers Crown Removers Curettes Fracture Finders Glass Ionomer Cement (GIC) Applicator Gun Glass Ionomer Cement (GIC) Activator Gun Instrument Accessories - Cassettes Instrument Accessories - Instrument Trays Instrument Accessories Instrument Sharpeners Instrument Preparation - Burnishers Instrument Preparation - Carvers Instrument Preparation - Chisels Instrument Preparation - Excavators Instrument Preparation - Explorers Instrument Preparation Periodontal Probe Instrument Preparation - Hatchets Instrument Preparation Margin Trimmers Instrument Preparation Plastic Instrument Intraligamentary Syringes Mirrors Mirrors Accessories - Handle Mouth Props Needle Holders Packers and Pluggers Retractors - Cheek Retractors - Lip Retractors - Tongue Rubber Dam Clamps Rubber Dam - Frames Safety Syringe System, Local Anaesthetics Scalers Scissors Page 5 of 84

6 Table of Contents 5.40 Tweezers Category 6 - Laboratory Products Acrylic Resin Cold Cure Acrylic Resin Heat Cure Bleaching - Bleaching Trays Bleaching - Gingival Barriers Casting and Investing - Crucibles Casting and Investing - Investments Casting and Investing Non-Precious Alloy Casting and Investing Semi-Precious Alloy Casting and Investing - Precious Alloy Casting and Investing - Solder Casting and Investing Lab Putty Ceramics and Composites Indirect Composites Ceramics and Composites Machinable Ceramics Ceramics and Composites Ceramics Dental Compound Cake Dental Compound Stick Dental Plasters Dental Stones Finishing and Polishing Finishing Mops Finishing and Polishing Finishing Polish / Paste Finishing and Polishing Finishing Pumice Finishing and Polishing Sandblasting Materials Investment Accessories Model Fabrication Duplicating Material Model Fabrication Gypsums Model Fabrication Model Preparation Model Fabrication Pin / Model systems Model Fabrication Saw Blades Model Fabrication Separators Plaster Cutters Polishers Brushes Polishers Buffs Preformed Patters Preformed Wax Patterns Prosthetics Characterisation Kits Prosthetics Separating Agents Page 6 of 84

7 Table of Contents 6.36 Prosthetics Teeth Putties and Silicones Gingival Silicone Soft Relining Material - Temporary Soft Relining Material - Permanent Wax - Baseplate Wax - Boxing Wax - Carving Wax Casting Sheets Wax - Dipping Wax - Inlays Wax - Periphery Wax - Sprues Wax - Sticky Waxing Instruments Category 7 - Orthodontics Products Arch Wire, Components and Attachments Banding Systems Buccal Tubes Cephalometric Accessories Marking Instruments Cephalometric Accessories Measuring Instruments Coil Spring Disc Guard Double Sided Stripping Disc Facebows Forceps - Orthodontic Headgear Systems and Oral Screen Intraoral Mirror Ligature Wire Systems Lingual Attachments Orthodontic Brackets Orthodontic Cement / Resin Systems Orthodontic Cement / Resin Systems - Orthodontic Mixes Orthodontic Cement / Resin Systems - Associated Applicators Orthodontic Elastics Orthodontic Storage Systems Orthodontic Screws Photographic Camera Page 7 of 84

8 Table of Contents 7.23 Pliers Retainer Boxes Retraction Suction System Thermoforming Material Tongue Depressors Wax Orthodontic Wire Cutters Category 8 - Preventative Products Disclosing Products Floss Flouride Products Gels Flouride Products Varnishes Flouride Products Foams Flouride Products Flouride Trays Mouth Guard Blanks Prophy Brushes Prophy Cups Prophy Paste Tooth Mousse Category 9 - Restorative Products Caries Detectors Cements / Liners Calcium Hydoxide (CaOH) Liners Cements / Liners Glass Ionomer Cement (GIC) Cements Cements / Liners Resin Cements Composite Resin Bonding - Kits Core Build-Up Crowns Stainless Steel Filling Material - Amalgams Filling Material Composites, Anterior Filling Material Composites, Posterior Filling Material Composites, Flowable Filling Material Flow Dispensing Tips Filling Material Glass Ionomer Cement (GIC) - Self Cured Filling Material Glass Ionomer Cement (GIC) - Light Cured Filling Material Resin Modified Glass Ionomer Cement (RMGIC) Filling Finishing and Polishing Finishing Pastes Finishing and Polishing Finishing Strips Page 8 of 84

9 Table of Contents 9.18 Fissure Sealant Matrices and Wedges Matrix Bands, Sectional Matrices and Wedges Matrix Bands, Siqveland Matrices and Wedges Matrix Bands, Retainerless Matrix System Matrices and Wedges Matrix Bands, Tofflemire Matrices and Wedges Matrix Retainers (Bands) Matrices and Wedges Matrix Retainers (Sectional) Matrices and Wedges Matrix Strips Matrices and Wedges Wedges Matrices and Wedges Cervical System Kit Matrices and Wedges Cervical System Kit Refills Matrices and Wedges Sectional System Kit Matrices and Wedges Sectional System Kit Refills Pins Posts Resin Bonding System - Primer Resin Bonding System - Sealer Resin Bonding System Etch Resin Bonding System Primer / Sealer combination Resin Reinforcement Ribbon Temporary Cement Temporary Crown Forms Category 10 - Surgical Products Bone Files Bone Trimmers Elevators Forceps Haemostats Luxators E Appendices Appendix 1 - Product List Appendix 2 - References A 2.a Standards A 2.b Guidelines and Other References Page 9 of 84

10 Introduction A Introduction 1 Purpose a. The purpose of this -, is to: (i) (ii) detail the scope and range of products sought under this Invitation to Supply (ITS) specify the requirements that Respondents and / or their offered products must meet (these requirements also form part of any resulting Agreement between HPV and any successful Respondent) 2 Scope a. HPV is seeking responses for for use in Participating Health Services. The envisaged Term of the Agreement is two (2) years plus one optional two year extension periods (e.g. 2+2). b. The scope of this ITS includes: (i) the supply of the products listed in section -A3 - Product Categories. Some of the dental consumables use in dental procedures such as anaesthetic, evacuation, infection control, waxes and compound are re-assigned under the other categories listed in section A3 Product Categories. c. The scope of this ITS does not include the: (i) (ii) (iii) (iv) (v) (vi) (vii) supply of Dental Anaesthetics (except needles and syringes without drugs); supply of Dental Equipment; supply of Dental Handpieces; supply of Dental Implants; supply of Radiography & Imaging Equipment and its consumables; supply of Dental Pharmaceutical; and supply of products that are already part of other established HPV contracts. 3 Product Categories a. The categories of required under this ITS include: (i) Category 1 Burs; (ii) Category 2 Endodontics products; (iii) Category 3 General Consumables; (iv) Category 4 Impression products; (v) Category 5 Instruments and accessories; (vi) Category 6 Laboratory products; (vii) Category 7 Orthodontics products; (viii) Category 8 Preventative products; (ix) Category 9 Restorative products; Page 10 of 84

11 Introduction (x) Category 10 Surgical Products. b. The Respondent may offer products in one, some or all categories. c. Only products that specifically fit within the category description provided will be considered. d. Preference to offers with the greatest range and best value for money across and/or within product categories (with the exception of niche product ranges) may be given. e. HPV reserves the right not to consider any additional products offered. f. For a full list of product categories and subcategories, see Appendix 1 - Product List. 4 Product Conditions 4.1 Clinical Trials a. Participating Health Services may, at their discretion, research or trial new technology or use non-contracted products to perform clinical trials at any time during the Term of any resulting Agreement. 4.2 Product Duplication a. HPV will not consider any product that is subject to a current HPV Agreement. b. The Respondent will ensure that each product is offered in only one subcategory. It is at the Respondent s discretion to ensure that each product is submitted in the most appropriate subcategory. 4.3 Product Information a. The Respondent will submit a copy of relevant product diagrams, specifications or brochures to assist in accurately identifying products offered. b. Where research papers or relevant scientific information is available, this should be submitted with the Response. c. All product information submitted should: (i) (ii) (iii) (iv) (v) (vi) (vii) be in electronic format be in English be specific to the product offered contain the Respondent s company name include the product code include a detailed specification of the product include clear diagrams/pictures of the product. d. To assist in managing this material, all product information submitted needs to be labelled with the relevant HPV category and subcategory number. Page 11 of 84

12 Introduction Electronic copies must include the HPV Category and subcategory numbers in the filename or identifying metadata. HPV may not consider unlabelled submissions. e. Product information will not be evaluated, but is necessary to assist in accurately identifying products offered. f. HPV reserves the right to exclude products from evaluation when the product is unidentifiable and provided information is: (i) not labelled as per A 4.3 d above; or (ii) is incomplete as to A 4.3 c. g. The Respondent should not submit information relating to products that are not called for in this ITS. h. Respondents are to provide for evaluation purposes samples of submitted products and accessories. This is to include: (i) (ii) (iii) (iv) (v) one (1) sample of one (1) size for each product type of each range or sub-category; single use or re-usable; sterile or non-sterile; a list of all samples provided; and instructions for use, where applicable. i. All samples provided should be: (i) (ii) (iii) new and unopened; packed, sealed and labelled; and include supporting specifications and relevant data. j. Each sample submitted should be clearly labelled with the following information: (i) (ii) (iii) (iv) name of the Respondent; ITS name and number; name and number of the sub-category that the product has been tendered into; and product code and description. k. All samples submitted will be disposed of upon completion of the evaluation process unless collection or return instructions are supplied with each sample. Samples to be returned will be at Respondent s cost. l. For samples to be returned, Respondents are to include instructions with the samples with the following: (i) Clear instructions to indicate if the samples are to be collected from HPV or are to be sent back at the Respondent s cost. For samples that are to be sent back, instructions are to include the freight account or con note, an address print out and any necessary paperwork that is to be used by HPV to enable the return to occur. m. Samples are to be sent to the following address: Page 12 of 84

13 Introduction Attention to: Jared Tang Health Purchasing Victoria Level 34, Casselden Place, 2 Lonsdale Street Melbourne, VIC 3000 n. All samples are to arrive at the above address before the Tender Closing Date and Time 5 Definitions a. The following definitions apply to this, unless otherwise stated. TERM Agreement ARTG business day GS1 GTIN HPV ITS may must normal use NPC OEM PHS Respondent DEFINITION A contract entered into by HPV and a Respondent for the provision of. Comprises the General Conditions, and all Schedules, Annexures of any kind and any attachments. Australian Register of Therapeutic Goods under the control of TGA Any weekday not gazetted as a public holiday in Melbourne, Victoria. Global Standards One Global Trade Identification Number Health Purchasing Victoria Invitation To Supply Indicates an optional element; it is at the Respondent s discretion to either meet or not meet this element, and failure to meet this element will not have an impact during evaluation. Indicates a mandatory requirement; failure to meet this requirement will result in the submission being eliminated from further consideration. Indicates that the item has undergone use for which it was manufactured and intended, and shows no signs of physical damage other than regular wear and tear. National Product Catalogue Original Equipment Manufacturer Participating Health Services - Public Hospitals and other Health or Related Services, as those terms are defined in Section 3 of the Health Services Act 1988 (Vic), that are described in Appendix 4 of Part 8. Any person, company or organisation responding to this ITS and, unless the context otherwise requires, includes those who may access the ITS for submitting a Tender. Page 13 of 84

14 Introduction TERM shelf life should single use SLA TGA TRW will DEFINITION The date indicator listed on products, whether it is listed as Best Before, Use By or another term. Indicates a highly desirable element; unless justifiable reason exists, not meeting this element may impact evaluation. A device that is intended to be used on an individual patient, during a single procedure, and then discarded. (Source: TGA, Regulation of the Re- Manufacture of Single Use Medical Devices). Service Level Agreement Therapeutic Goods Administration Tender Response Worksheet Indicates an anticipated future condition or requirement to be met. Page 14 of 84

15 Service, delivery, and support B Service, delivery, and support 1 Delivery a. must be delivered to the location(s) specified by Participating Health Services within the shortest possible timeframe; however, this must not exceed two (2) business days from receipt of order unless otherwise agreed with the Participating Health Service. b. All deliveries are bound as per the Draft Agreement, Part 7 9 Acceptance and Rejection of Deliverables. 2 Urgent Deliveries a. For the purposes of this section, urgent deliveries refers to urgent requests placed by an individual Participating Health Service, and does not include state-wide emergency situations. b. Urgent deliveries should be received by Participating Health Services within 24 hours from receipt of order. 3 Training a. Upon request by a Participating Health Service, successful Respondents will deliver a training package and/or training materials to facilitate the introduction of their Dental Consumables to clinicians in their operating environment. b. Training requirements may include (but are not limited to): (i) (ii) (iii) (iv) (v) face-to-face training at Participating Health Service sites (i.e. in-service training) off-site study days for clinicians updates and refresher training on new products and/or equipment and surgical techniques training on cleaning and sterilisation to nominated personnel and the Participating Health Services CSSD and SSU (for reusable instruments) training materials. c. If requested by a PHS, successful Respondent must provide an education plan detailing how they will provide training to nominated staff. Note that the number of staff involved in training may vary greatly between PHS d. Successful Respondent must ensure that the following is available to PHS (in either hardcopy or electronic format): (i) (ii) (iii) the credentials of any staff who would be providing support in Victoria; the hours of availability for support; the geographical area covered by the support (if support is available on-site); and Page 15 of 84

16 Service, delivery, and support (iv) details of educational and/or support materials available to clinicians. e. All training regimes must be implemented and include appropriate levels of training to meet Workplace Health & Safety standards as required by The Victorian WorkCover Authority. 4 Customer Service and Support a. The successful Respondent must be able to deliver prompt customer service and support to Participating Health Services. b. The successful Respondent will nominate at least one Representative as the key account manager to provide the support and to work closely with the PHS and HPV. c. The successful Respondent will provide Participating Health Services with representatives that are: (i) (ii) (iii) (iv) (v) inherently familiar with the contracted products appropriately qualified technically/clinically knowledgeable about the contracted products available to respond to Participating Health Services queries during business hours representatives are required to have a valid Police Check and may require a Working with Children Check. d. It is desirable that nominated Representatives have a clinical background or experience. e. The level of customer service and support required of Representatives is expected to include (but is not limited to): (i) (ii) (iii) (iv) (v) (vi) liaising with clinicians to recommend products and solutions promptly answering clinicians queries liaising with various hospital departments (for example: operating theatre, Dental Unit Managers, Infection Prevention Manager, Supply Managers) providing on-site clinical support during cases (if requested) providing informational materials providing education and in-service training upon request. 5 Warranty a. All products covered in this ITS (including relevant instrument sets and loan kits) are to be issued a warranty for a minimum or twelve (12) months from the delivery date for normal use. b. Upon request, the successful Respondent will provide information (printed or electronic) explaining product warranty. 5.2 Replacements under Warranty a. The replacement of any item under warranty will be at no cost to the Participating Health Service. Page 16 of 84

17 Service, delivery, and support b. The cost of any pickup or delivery associated with a repair or replacement under warranty will be borne by the successful Respondent. 6 Key Performance Indicators a. Refer to Draft agreement - Performance Indicators. 7 Reporting a. Refer to Draft agreement - reporting requirements. 8 Service Level Agreement a. Participating Health Services may enter into a Service Level Agreement (SLA) with the successful Respondent(s). The SLA may cover arrangements including, but not limited to: (i) (ii) (iii) (iv) requirements for stock management and rotation arrangements for ordering, invoicing and delivery clinical support, including attendance requirements for Representatives in relation to education and training communication arrangements for product recalls and safety alerts (refer to C3 Recallnet). b. The SLA will be in addition to the Agreement between the successful Respondent(s) and HPV, and will not alter any terms of the Agreement. c. HPV will not be responsible for monitoring compliance with any SLA. This is a matter of agreement between the parties to the SLA. d. Successful Respondent(s) will provide a copy of all Service Level Agreements to HPV within 1 week of being finalised. Page 17 of 84

18 General Requirements C General Requirements 1 Standards and Compliance a. All items offered must comply with relevant Australian Standards (or their equivalent International Standards). Refer to Appendix 2 - References for a list of the minimum relevant standards. b. All items offered must be approved by the Australian Therapeutic Goods Administration (TGA), where applicable. The Respondent must provide evidence of this (i.e. ARTG certificates) in its response. c. The successful Respondent must provide evidence of ARTG certification to Participating Health Services upon request. 2 Packaging and Labelling a. Products must be packaged to retain the structural integrity of the enclosed product. b. Sterile products will be packaged in a manner that protects the contents from contamination during transportation, storage and handling. c. Packaging must protect products with sharp points or edges (e.g. needles, where present) and be safe when packages are handled. d. All labels must comply with the Therapeutic Goods Order No. 37: General Requirements for Labels for Therapeutic Goods. e. Items will be delivered in accordance with the manufacturer s instructions. f. It is a requirement for individual product packaging to include (where applicable): (i) (ii) (iii) (iv) whether the product is sterile; whether the product is MRI compatible (implantable products); whether the product (or packaging) contains latex or is latex-free; and tracking labels. 3 Recall Process a. All recalls must be managed in line with the Uniform Recall Procedure for Therapeutic Goods (2004). b. Within six (6) months of contract commencement, all recalls and/or hazard alerts will be completed using GS1 Recallnet. c. Class 1 recalls (as defined by the TGA s Uniform Recall Procedure for Therapeutic Goods) must also meet the requirements under section - B5 Warranty, where applicable. Page 18 of 84

19 General Requirements 4 Backorders and Discontinued Lines a. In the event that a product is unavailable for a period of two or more consecutive weeks, the successful Respondent will contact (at a minimum) the following: (i) (ii) (iii) (iv) Procurement Officers of all Participating Health Services Clinical Staff Supply Manager / Business Managers of all Participating Health Services HPV b. In the event that an item is discontinued, successful Respondents will notify Participating Health Service staff and HPV (as per clause a) as soon as possible, but no less than six (6) months before the last date of manufacture. c. Successful Respondents will inform the affected Participating Health Services and HPV of: (i) (ii) the anticipated timeframe for resolving the issue the availability of an agreed substitute product 5 Infection Control a. Where applicable, all items must meet the requirements of the Australian Guidelines for the Prevention and Control of Infection in Healthcare (2010). b. Documentation and reprocessing instructions relevant to Australian standards AS/NZS 4187 are to be provided by successful Respondents to the Participating Health Services if supplying products and instruments that can be reusable. 6 Superseded Products a. Where a contracted item is superseded, the new product must be offered at the same price as the original item. This change request must be submitted to HPV for approval through HPV s Contract Variation process. 7 Shelf Life a. Producs that have an Expiry Date (where applicable) are to have a minimum of six (6) months shelf life on delivery to all PHS. 8 Reference Sites a. Respondent are required to provide a minimum of three (3) Australian clinical references that are purchasing or have trialled and evaluated the product offered in this submission. Page 19 of 84

20 General Requirements b. Where a product category contains a variety of specific sub-categories, Respondent are to ensure that the clinical references provided are representative of the full range of products tendered. c. HPV reserves the right to verify this information with health services personnel and seek user feedback as to the acceptability of these products. d. Respondent should not nominate a referee without their express permission. Page 20 of 84

21 D Product Specifications 1 Substances of Concern a. Preference will be given to products (including their accompanying packaging) that are latex-free, unless otherwise stated. b. Preference may be given to products that are free of phthalate content, particularly diethylhexyl phthalate (DEHP). 2 Instrument Trays a. All instrument trays will be provided with tray lists. b. Instrument trays must be suitable for sterilisation in line with AS/NZS c. Instrument trays (including all contents) will weigh less than five (5) kilograms. 3 Category Specifications a. A complete range of is required for treatment of patients across Victorian Public Health Services. b. Products offered with optional components are to also comply with the specifications for other relevant categories (where applicable). Page 21 of 84

22 Category 1 - Burs a A specified range of dental Burs is required to meet clinical needs of products from subcategory 1.01 to 1.11 as per Appendix 1 Product List. This includes: i. a specified range of sizes and configuration; ii. sterile and non-sterile; iii. single use (disposable) and re-usable; iv. brand name; v. manufacturer name; vi. type of material that product is made of; vii. international codes (e.g. ISO, colour, sizes); and viii. autoclave compatible or not autoclave compatible. b For each product offered in the subcategories below, Respondent must provide the following information in the Product Description on the Tender Response Worksheet: 1.01 Burs, Diamond - Finishing and Polishing Head Shape Shank Length Grit Type Shank Type Flame Standard Medium/Fine/Extra Fine FG (Friction Grip) Football Standard Medium/Fine/Extra Fine FG (Friction Grip) Pear Standard Medium/Fine/Extra Fine FG (Friction Grip) Wheel Standard Medium/Fine/Extra Fine FG (Friction Grip) Large round ball Standard Medium/Fine/Extra Fine FG (Friction Grip) Taper end fissure Standard Medium/Fine/Extra Fine FG (Friction Grip) Taper fissure Standard Medium/Fine/Extra Fine FG (Friction Grip) Flame Standard Fine/Extra Fine RA (Right Angle) Football Standard Medium/Fine/Extra Fine RA (Right Angle) Round Standard/Long Medium/Fine/Extra Fine RA (Right Angle) Polishing point rubber green Standard RA (Right Angle) Page 22 of 84

23 Polishing point rubber Brown Standard RA (Right Angle) Green stone point Standard FG (Friction Grip) Barrell Standard Medium/Fine/Extra Fine FG (Friction Grip) 1.02 Burs, Diamond - Restorative Head Shape Shank Length Grit Type Shank Type Size Flat Fissure Standard Medium/Coarse FG (Friction Grip) Long Flat Fissure Standard Medium/Coarse FG (Friction Grip) Inverted Cone Medium/Coarse Small Round Medium/Coarse Medium Round Medium/Coarse Round End Cylinder Medium/Coarse Pulp Bur Long FG (Friction Grip) 14 Pulp Bur ( Endo) Long FG (Friction Grip) Burs, Steel - Restorative Head Shape Shank Length Shank Type Size Round Standard RA (Right Angle) 0.50 Round Standard RA (Right Angle)) 1 Round Standard RA (Right Angle) 2 Round Standard RA (Right Angle) 3 Round Standard RA (Right Angle) 4 Page 23 of 84

24 Round Standard RA (Right Angle) 5 Round Standard RA (Right Angle) 6 Round Standard RA (Right Angle) 7 Round Standard RA (Right Angle) 8 Round Standard RA (Right Angle) 9 Round Standard RA (Right Angle) 10 Round Standard RA (Right Angle) 11 Round Standard RA (Right Angle) Burs, Steel - Surgical Head Shape Shank Length Shank Type Size Round Oral Surgery For Straight Handpiece Straight 8 Bone Cutter For Straight Handpiece Straight 16 Surgical Standard FG (Friction Grip) 1.05 Burs, Steel - Acrylic Stainless Steel Head Shape Grit Type Shank Type Acrlylic Polishing Bur Green Coarse Straight Acrylic Polishing Bur Grey Medium Straight Acryllic Polishing Bur Dark Blue Coarse Straight Page 24 of 84

25 Bur Lab Cutter Straight Trimmer Bullet Straight Tungsten Carbide Cross Cut Straight Bud Straight Disc Wheel 1.06 Burs, Tungsten Carbide - Finishing and Polishing Head Shape Shank Type Flame FG (Friction Grip) Round FG (Friction Grip) Pear FG (Friction Grip) Fine Tip FG (Friction Grip) 8 Blade FG (Friction Grip) 16 Blade FG (Friction Grip) Occulsal Polisher FG (Friction Grip) Proximal Polisher FG (Friction Grip) Palatal Polisher FG (Friction Grip) Labial Polisher FG (Friction Grip) 1.07 Burs, Tungsten Carbide - Restorative Page 25 of 84

26 Head Shape Shank Length Shank Type Size Round Standard FG (Friction Grip) 5 Round Standard FG (Friction Grip) 6 Round Standard FG (Friction Grip) 7 Round Standard FG (Friction Grip) 8 Round Standard FG (Friction Grip) 9 Round Standard FG (Friction Grip) 10 Round Standard FG (Friction Grip) 12 Round Standard 14 Round Standard RA (Right Angle) 16 Round Standard RA (Right Angle) 18 Inverted Cone Standard FG (Friction Grip) / RA (Right Angle) 6 Inverted Cone Standard FG (Friction Grip) / RA (Right Angle) 8 Inverted Cone Standard FG (Friction Grip) / RA (Right Angle) 10 Inverted Cone Standard FG (Friction Grip) / RA (Right Angle) 12 Inverted Cone Standard FG (Friction Grip) / RA (Right Angle) 14 Inverted Cone Standard FG (Friction Grip) / RA (Right Angle) 16 Inverted Cone Standard FG (Friction Grip) / RA (Right Angle) 18 Taper Standard FG (Friction Grip) Amalgam Remover Standard FG (Friction Grip) 1.08 Burs, Tungsten Carbide - Surgical Page 26 of 84

27 Head Shape Shank Type Round Straight Cone Straight 1.09 Bur Stands Type Number of hole/slots Note Bur guard-stand Autoclavable 12 Hole Must hold both FG (Friction Grip) and RA (Right Angle) Bur guard-stand Autoclavable 22 Hole Must hold both FG (Friction Grip) and RA (Right Angle) 1.10 Mandrels Type Note Polishing Disc Mandrel Must relate to consumables tendered 1.11 Polishing Discs Type Grit Type Size Polishing Disc Coarse Standard 9.5mm approx Polishing Disc Medium Standard 9.5mm approx Polishing Disc Fine Standard 9.5mm approx Polishing Disc Extra Fine Standard 9.5mm approx Polishing Disc Coarse Extra Thin (XT) 9.5mm approx Polishing Disc Medium Extra Thin (XT) 9.5mm approx Polishing Disc Fine Extra Thin (XT) 9.5mm approx Page 27 of 84

28 Polishing Disc Extra Fine Extra Thin (XT) 9.5mm approx Polsihing Disc Coarse Standard 12.5mm approx Polishing Disc Medium Standard 12.5mm approx Polishing Disc Fine Standard 12.5mm approx Polishing Disc Extra Fine Standard 12.5mm approx Polishing Disc Coarse Extra Thin (XT) 12.5mm approx Polishing Disc Medium Extra Thin (XT) 12.5mm approx Polishing Disc Fine Extra Thin (XT) 12.5mm approx Polishing Disc Extra Fine Extra Thin (XT) 12.5 mm approx Page 28 of 84

29 Category 2 - Endodontics a A full range of dental Endodontics products is required to meet clinical needs of products from subcategory 2.01 to 2.21 as per Appendix 1 Product List. This includes: i. a full range of sizes and configuration; ii. sterile and non-sterile; iii. single use (disposable) and re-usable; iv. brand name; v. manufacturer name; vi. type of material that product is made of; vii. international codes (e.g. ISO, colour, sizes); and viii. autoclave compatible or not autoclave compatible. b For each product offered in the subcategories below, Respondent must provide the following information in the Product Description on the Tender Response Worksheet: 2.01 Bleaching Material i. size; ii. peroxide %; iii. delivery system (e.g. take home, paint on); and iv. exposure time (e.g. day or night) Broaches Barbed i. blade length dimensions (mm); and ii. sizes Broaches Smooth i. blade length dimensions (mm); and ii. sizes Cements and Sealers i. delivery system (e.g. powder, liquid, kit); and ii. generic product name Drills Gates Glidden i. sizes Drills - Peeso i. sizes Drills Fillers and Spirals Page 29 of 84

30 i. working length (mm); and ii. sizes Files Hand i. shapes (cross section); ii. working length (mm); and iii. sizes Files - Pathfinders i. length (mm); and ii. sizes (e.g. 1-4) Files - Reamers i. shapes (cross section); ii. working length (mm); and iii. sizes Files - Rotary i. shapes; ii. cut (e.g. smooth, medium, rough); iii. working length (mm); iv. taper dimensions; v. sizes; vi. rotation type (e.g. oscillate); and vii. delivery system name. Note: Suppliers to provide details of associated GP and paper point products Fingers Pluggers and Spreaders i. length (mm); and ii. sizes Gauges and Rulers i. length (mm); ii. with or without depth guides; iii. material of high heat resistance; and iv. reprocessable (e.g. autoclavable) Irrigation - Solutions i. type solution type; and Page 30 of 84

31 ii. solution concentration (e.g. 6% solution) Medicaments i. type (e.g. Calcium hydroxide paste, Zinc oxide paste); ii. solution concentration (e.g. 6% solution); and iii. delivery system (e.g. single use) Points - GP i. sizes; and ii. length in mm Points - Paper i. sterile and non-sterile; ii. length; and iii. sizes Post Endodontics Bleaching Products i. type (e.g. mineral trioxide aggregate - MTA); and ii. concentration Rings and Stoppers i. type of material (e.g. silicone); and ii. sizes Storage Accessories i. number of instruments that can be held; ii. box sizes (mm); and iii. be able to hold and organise instruments, other endodontics products for staging, cleaning and sterilizing Temporary Filling i. delivery system (e.g. 0.34g capsule, jar, or single dose). Page 31 of 84

32 Category 3 - General Consumables a A full range of general consumables products is required to meet clinical needs of products from subcategory 3.01 to 3.27 as per Appendix 1 Product List. This includes: i. a full range of sizes and configuration; ii. sterile and non-sterile; iii. single use (disposable) and re-usable; iv. brand name; v. manufacturer name; vi. type of material that product is made of; vii. international codes (e.g. ISO, colour, sizes); and viii. autoclave compatible or not autoclave compatible. b For each product offered in the subcategories below, Respondent must provide the following information in the Product Description on the Tender Response Worksheet Air Water Syringe Tips i. type; ii. colours; iii. overall length (mm); iv. to provide compatibility information to chair type system; and v. availability of adapter type 3.02 Anaesthetics Needles i. needle gauge (e.g. 22G); ii. needle length (mm); iii. needle wall type (e.g. thin wall); and iv. delivery system (e.g. safety hub, single use) Applicator, one-piece - Micro-Brushes i. sizes (e.g. fine, regular); ii. handle length (mm); iii. tip (e.g. bendable); and iv. single use Applicator, one-piece - Multi-Brushes i. sizes (e.g. fine, regular); ii. handle length (mm); iii. tip (e.g. bendable); and iv. single use Articulating - Papers i. colour; Page 32 of 84

33 ii. iii. iv. thickness (e.g. 63 microns); shape (e.g. horseshoe, booklet, strips); and single use Aspirator Tube - Disposable i. latex free; ii. colours; iii. overall length (mm); iv. shape (e.g. curly, straight); and v. removeable tip Barriers and Drapes Products i. barrier coverage (e.g. equipment, handle cover, sleeve); ii. dimensions (mm); iii. drape coverage (e.g. dental equipment, sleeves); iv. colour; v. material (e.g. nylon, plastic, polyester/tissue, polypropylene); and vi. degradeable or non degradeable Bibs i. bib construction (e.g. 1,2,3,4 ply); ii. color; iii. attachment type (e.g. adhesive tieon, none); iv. size; and v. single use Bib Chains i. bib attachment type (e.g. chain, adhesive, clip); ii. color; and iii. compatible sterilization (autoclave, chemiclave, dry heat) Cotton Products Cotton Guards i. sizes (mm); and ii. single use Cotton Products Cotton Haemostat and Pledgets i. sizes (mm); and ii. single use Cotton Products Cotton Pellets Page 33 of 84

34 i. pellet size (e.g. # 00, 0-5); and ii. single use Cotton Products Cotton Rolls i. sizes; and ii. single use Dappen Dishes i. single use; ii. material (e.g. paper, plastic); and iii. capacity Dental Impression Solutions - Disinfection Material i. standards met (e.g. CDC, OSHA); ii. product form (e.g. liquid concentrate); iii. container type (e.g. spray bottle); iv. container size; v. reuse life (e.g. 60 day); vi. scent; vii. shelf life (e.g. 6 months); viii. activator type (e.g. activator required); ix. cleaner colour (e.g. Natural); x. organisms killed (e.g. HIV, Hepatitis Viruses, MRSA, Staph, Tuberculosis); and xi. cleaning agent type (e.g. bactericide, virucide) Dental Water-Unit Treatment - Tablets i. type of tablets; and ii. container type Disposable Holders - Wells i. type of material; ii. sizes; and iii. colour. Page 34 of 84

35 3.18 Distilled Water i. sizes Gingival Retraction Cords i. presoaked or not-presoaked; and ii. sizes Gingival Retraction Haemostatic Solutions i. type of solution; ii. container size; iii. container material; and iv. concentration Haemostatic Sponges i. sizes Mixing Pad for Impression and Restorative Material i. shapes; and ii. sizes Rubber Dam Sheets i. single use; ii. dimensions; iii. thickness; and iv. colours Rubber Dam Accessories - Interproximal Elastic Stabiliser i. single use; ii. type; iii. sizes; and iv. colours Saliva Ejectors i. colours; ii. overall length (mm); iii. shape (e.g. curly, straight); and iv. removeable tip. Page 35 of 84

36 3.26 Suction Tube Adaptor i. slow or high speed; and ii. sizes Suction Tube Single Use i. colour; ii. single use; and iii. tip diameter (mm). Page 36 of 84

37 Category 4 - Impression Products a A full range of dental impression products is required to meet clinical needs of products from subcategory 4.01 to 4.14 as per Appendix 1 Product List. This includes: i. a full range of sizes and configuration; ii. sterile and non-sterile; iii. single use (disposable) and re-usable; iv. brand name; v. manufacturer name; vi. type of material that product is made of; vii. international codes (e.g. ISO, colour, sizes); and viii. autoclave compatible or not autoclave compatible. b For each product offered in the subcategories below, Respondent must provide the following information in the Product Description on the Tender Response Worksheet: 4.01 Bite Registration Silicone i. single use; ii. set time; and iii. material properties Bite Registration Wax i. single use; ii. colour; iii. sizes; and iv. set time Denture Pressure Indicator Paste i. Colour Impression Adhesives i. sizes; and ii. type of impression material compatibility Impression Dispensing Tools i. type; ii. sizes; and iii. impression material compatibility Impression Tray Cleaners i. type (e.g. liquid). Page 37 of 84

38 4.07 Materials - Impression Addition Silicone i. colours; ii. sizes; and iii. setting Materials - Impression Alginate i. set time (e.g.slow or fast setting); ii. flavours; iii. body / viscosity; and iv. colours Materials - Impression Polyether i. body / viscosity; ii. colours; and iii. delivery system Materials - Impression Polyvinyl Silaxane i. body/viscosity; ii. set time; and iii. delivery system Materials - Impression Zinc Oxide Eugenol (ZOE) i. body/viscosity; ii. set time; and iii. colours Spatulas i. number of ends (e.g. single); ii. compatible working material (e.g. cement, plaster); iii. blade material (e.g. copper, plastic); iv. blade length; v. blade flexibility (e.g. flexible, stiff); vi. sizes; and vii. handle material Trays - Metal i. quadrant / arch (e.g. upper); ii. perforated and non-perforated; iii. sizes (e.g. medium); and iv. edentulous or dentate Trays - Single use, disposable Page 38 of 84

39 i. quadrant / arch (e.g. upper); ii. sizes (e.g. medium); and iii. edentulous or dentate. Page 39 of 84

40 Category 5 - Instruments and Accessories a A full range of dental Instrument and Accessories is required to meet clinical needs of products from subcategory 5.01 to 5.40 as per Appendix 1 Product List. This includes: i. a full range of sizes and configuration; ii. sterile and non-sterile; iii. single use (disposable) and re-usable; iv. brand name; v. manufacturer name; vi. type of material that product is made of; vii. international codes (e.g. ISO, colour, sizes); and viii. autoclave compatible or not autoclave compatible. b For each product offered in the subcategories below, Respondent must provide the following information in the Product Description on the Tender Response Worksheet: 5.01 Amalgam Carriers i. number of ends (e.g. single); ii. handle shape (e.g. round); iii. handle material (e.g. stainless steel, acetal resin); and iv. reprocessable (e.g. autoclavable) Applicator Instruments i. end type (e.g. dispenser, brush tip); ii. tip (e.g. ultra fine, extra fine, super fine, fine, medium, regular, cylinder); and iii. kit Articulating Paper Holder i. sizes Aspirating Syringes i. volume of syringe cartridge (ml); ii. type of material; and iii. aspirating or non aspirating Composite Gun i. compatible cartridge capacity; and ii. composite material compatibility Composite Instruments i. tip shape (e.g. acorn, ball, carver); Page 40 of 84

41 ii. number of ends (e.g. double, single); iii. tip material (e.g. anodized aluminium, plastic, stainless steel, titanium, nitride); iv. tip type; and v. handle type Cord Packers i. number of ends; ii. tip texture (e.g. serrated, smooth); iii. tip material; and iv. handle material Crimping Pliers i. includes cutter (e.g. non-cutting); ii. locking or non-locking; and iii. tip texture (e.g. smooth) Crown Removers i. number of ends (e.g. single); ii. remover type; iii. tip shape (e.g. straight, angled 45, 60, 90 degrees); and iv. handle type Curettes i. tip type (gracey, universal); ii. sizes; iii. number of ends; iv. blade type; v. shank type (e.g. shortened, extended, standard); and vi. handle shape (e.g. hexagonal, octagonal, round) Fracture Finders i. colours; ii. sizes Glass Ionomer Cement (GIC) Applicator Gun i. compatible cartridge capacity Glass Ionomer Cement (GIC) Activator Gun i. compatible cartridge capacity. Page 41 of 84

42 5.14 Instrument Accessories - Cassettes i. part type; ii. compatible cassette series; iii. colours; iv. capacity; and v. material Instrument Accessories - Instrument Trays i. size code (e.g. B,F ); ii. tray surface type (e.g. divided, flat); iii. colours; and iv. material Instrument Accessories Instrument Sharpeners i. product type; ii. grit (e.g. extra-fine, fine, super-fine, coarse, medium); iii. oil use (e.g. not required, recommended, required); iv. sharpener shape (e.g. conical, cylindrical, rectangular, triangular, wedge); v. sharpener material (e.g. aluminium oxide, carbon steel, ceramic, plastic, silicon carbide, tungsten carbide); and vi. sizes Instrument Preparation - Burnishers i. number of ends (e.g. single, double); ii. tip type (e.g. acorn, ball); iii. design number; iv. tip diameter (mm); and v. handle type (e.g. standard) Instrument Preparation - Carvers i. number of ends (e.g. double, single); ii. tip type (e.g. acorn, Andrew); iii. tip material (e.g. carbide, carbon steel, stainless steel); and iv. handle type Instrument Preparation - Chisels i. number of ends (e.g. double, single); ii. tip type (e.g. Gardner); iii. handle type; iv. handle material; and v. tip material. Page 42 of 84

43 5.20 Instrument Preparation - Excavators i. number of ends; ii. handle type; iii. design; iv. application; v. tip diameter (mm); vi. sizes; and vii. tip type (e.g. spoon, endo) Instrument Preparation - Explorers i. number of ends; ii. tip type (e.g. sickle, straight); iii. handle type; and iv. handle shape (e.g. octagonal, round) Instrument Preparation Periodontal Probe i. number of ends; ii. tip type (e.g. sickle, straight); iii. handle type; and iv. handle shape (e.g. octagonal, round) Instrument Preparation - Hatchets i. number of ends; ii. design; iii. handle type; iv. handle material; and v. tip material Instrument Preparation Margin Trimmers i. number of ends; ii. design; iii. handle type; iv. handle material; and v. tip material Instrument Preparation Plastic Instrument i. plastic filling instruments; ii. tip shape; iii. number of ends; iv. tip material; v. sizes; and vi. handle type. Page 43 of 84

44 5.26 Intraligamentary Syringes i. cartridge size Mirrors i. type of mirror; ii. mirror size; iii. material (e.g. stainless steel, plastic disposable); iv. handle shape; v. handle taper (e.g. straight, tapered); vi. connection type (e.g. cone socket, simple stem); vii. number of sides (e.g. double or single sided); and viii. surface type Mirrors Accessories - Handle i. type (e.g. attachment) Mouth Props i. type; ii. sizes; and iii. latex free Needle Holders i. tip shape (e.g. round, straight); ii. tip type; iii. tip texture (e.g. serrated, smooth); iv. material (e.g. carbide, stainless steel); v. compatible suture size; and vi. overall length (mm) Packers and Pluggers i. number of ends (e.g. double, single); ii. tip type (e.g. Marquette, Black); iii. tip shape (e.g. diamond, elliptical, rectangular, round, rhomboid); iv. tip texture (e.g. serrated, smooth); and v. handle type (e.g. 2 octagonal, 41 round, 6 satin steel, standard) Retractors - Cheek i. sizes; and ii. type (e.g. wire cheek, plastic cheek). Page 44 of 84

45 5.33 Retractors - Lip i. sizes; ii. type; and iii. material Retractors - Tongue i. sizes; ii. type; and iii. material Rubber Dam Clamps i. latex free; ii. tooth type (e.g. small lower canines and first premolars); and iii. style (e.g. wing or wingless) 5.36 Rubber Dam - Frames i. frame size; ii. material (plastic or metal) Safety Syringe System, Local Anaesthetics i. single use; ii. needle size; and iii. cartridge compatibility Scalers i. tip type (gracey, universal); ii. sizes; iii. number of ends; iv. tip shape; v. shank type (e.g. shortened, extended, standard); and vi. handle shape (e.g. hexagonal, octagonal, round) Scissors i. scissor type (e.g. Mayo); ii. blade shape (e.g. angled, curved, double-curved, straight); iii. tip shape (e.g. blunt, point); iv. blade texture (e.g. serrated, smooth); v. overall length; vi. blade material; vii. handle shape (e.g. curved, straight); and viii. handle material. Page 45 of 84

46 5.40 Tweezers i. tip shape (e.g. angled, curved); ii. tip texture (e.g. serrated, smooth); iii. material (e.g. plastic, stainless steel); and iv. locking or non-locking. Page 46 of 84

47 Category 6 - Laboratory Products a A full range of dental Laboratory products is required to meet clinical needs of products from subcategory 6.01 to 6.49 as per Appendix 1 Product List. This includes: i. a full range of sizes and configuration; ii. sterile and non-sterile; iii. single use (disposable) and re-usable; iv. brand name; v. manufacturer name; vi. type of material that product is made of; vii. international codes (e.g. ISO, colour, sizes); and viii. autoclave compatible or not autoclave compatible. b For each product offered in the subcategories below, Respondent must provide the following information in the Product Description on the Tender Response Worksheet: 6.01 Acrylic Resin Cold Cure i. colours; and ii. resin form (e.g. liquid or powder) Acrylic Resin Heat Cure i. colours; and ii. resin form (e.g. liquid or powder) Bleaching - Bleaching Trays i. resin form (e.g. liquid or powder) Bleaching - Gingival Barriers i. sizes Casting and Investing - Crucibles i. sizes; ii. material; and iii. colours Casting and Investing - Investments i. type of investment; ii. investment composition; iii. investment form (e.g. powder); and iv. colours. Page 47 of 84

48 6.07 Casting and Investing Non-Precious Alloy i. type of alloy; ii. alloy composition; iii. alloy form (e.g. powder); and iv. colours Casting and Investing Semi-Precious Alloy i. type of alloy; ii. alloy composition; iii. alloy form (e.g. powder); and iv. colours Casting and Investing - Precious Alloy i. type of alloy; ii. alloy composition; iii. alloy form (e.g. powder); and iv. colours Casting and Investing - Solder i. type of solder; ii. solder composition; iii. solder form (e.g. coil); and iv. colours Casting and Investing Lab Putty i. type of putty; ii. putty form (e.g. paste); iii. mixing ratio; and iv. colours Ceramics and Composites Indirect Composites i. type of composites; ii. composites form; iii. colours; and iv. sizes Ceramics and Composites Machinable Ceramics i. type of ceramics: ii. ceramic shapes; iii. colours; and iv. sizes. Page 48 of 84

49 6.14 Ceramics and Composites Ceramics i. type of ceramics (e.g. pressable) ii. ceramic shapes; iii. colours; and iv. sizes Dental Compound Cake i. type ii. colours; and iii. sizes Dental Compound Stick i. type ii. colours; and iii. sizes Dental Plasters i. type; ii. mixing ratio; iii. colours; and iv. setting time Dental Stones i. type; ii. sizes; and iii. setting time Finishing and Polishing Finishing Mops i. type; and ii. sizes; 6.20 Finishing and Polishing Finishing Polish / Paste i. type; and ii. sizes Finishing and Polishing Finishing Pumice i. type; and ii. sizes. Page 49 of 84

50 6.22 Finishing and Polishing Sandblasting Materials i. type; ii. form (e.g. pellet); and iii. sizes Investment Accessories i. type; ii. form; and iii. sizes Model Fabrication Duplicating Material i. type; ii. form; and iii. sizes Model Fabrication Gypsums i. type; ii. set time: iii. colours; iv. form; and v. sizes Model Fabrication Model Preparation i. type; ii. form; and iii. sizes Model Fabrication Pin / Model systems i. type; ii. form; and iii. sizes Model Fabrication Saw Blades i. type; and ii. sizes Model Fabrication Separators i. type; and ii. sizes. Page 50 of 84

51 6.30 Plaster Cutters i. type; and ii. sizes Polishers Brushes i. type; and ii. sizes Polishers Buffs i. type; and ii. sizes Preformed Patters Preformed Wax Patterns i. type; and ii. sizes Prosthetics Characterisation Kits i. type; and ii. sizes Prosthetics Separating Agents i. type; and ii. sizes Prosthetics Teeth i. type; and ii. sizes Putties and Silicones Gingival Silicone i. type; and ii. sizes Soft Relining Material - Temporary i. type; and ii. sizes Soft Relining Material - Permanent Page 51 of 84

52 i. type; and ii. sizes Wax - Baseplate i. type; and ii. sizes Wax - Boxing i. type; and ii. sizes Wax - Carving i. type; and ii. sizes Wax Casting Sheets i. type; and ii. sizes Wax - Dipping i. type; and ii. sizes Wax - Inlays i. type; and ii. sizes Wax - Periphery i. type ii. colours; and iii. overall length (mm) Wax - Sprues i. type; and ii. sizes Wax - Sticky Page 52 of 84

53 i. type; and ii. sizes Waxing Instruments i. type; and ii. sizes. Page 53 of 84

54 Category 7 - Orthodontics Products a A full range of dental Orthodontics products is required to meet clinical needs of products from subcategory 7.01 to 7.29 as per Appendix 1 Product List. This includes: i. a full range of sizes and configuration; ii. sterile and non-sterile; iii. single use (disposable) and re-usable; iv. brand name; v. manufacturer name; vi. type of material that product is made of; vii. international codes (e.g. ISO, colour, sizes); and viii. autoclave compatible or not autoclave compatible. b For each product offered in the subcategories below, Respondent must provide the following information in the Product Description on the Tender Response Worksheet: 7.01 Arch Wire, Components and Attachments i. gauge (e.g x 0.016); ii. shape (e.g. Rectangular); and iii. type (e.g. Lower Arch). All Arch Wires offered shall include: iv. stainless wires; v. Cobalt wires; vi. Ni-Ti Wires: vii. Ti-MB Wires: viii. Martensitic Wires: and ix. Low Ni Stainless Wires 7.02 Banding Systems i. tooth type (e.g. upper tooth); ii. sizes (e.g. U27); and iii. quadrant/arch Buccal Tubes i. tooth type (e.g. LL6, Lower Left First Molar); ii. type (e.g. Mandibular); iii. slot sizes (e.g and ); iv. torque (e.g. 20); v. rotation (e.g. 0); and vi. direct bond or weldable. All Buccal Tubes offered shall include: Page 54 of 84

55 vii. viii. ix. edgewise tubes; light wire tubes; and standard tubes Cephalometric Accessories Marking Instruments i. product type (e.g. label, marker); and ii. colours Cephalometric Accessories Measuring Instruments i. maximum measurement (e.g. up to 50mm) Coil Spring i. open or closed; and ii. force (e.g. light, medium, heavy) Disc Guard i. sizes (mm) Double Sided Stripping Disc i. sizes (mm); and ii. compatible straight hand piece type Facebows i. type (e.g. bag, neckpad); ii. inner bow diameter (mm); iii. sizes; and iv. length (mm) Forceps - Orthodontic i. type (e.g. Bracket, Mosquito); and ii. sizes Headgear Systems and Oral Screen i. type; and ii. colour Intraoral Mirror Page 55 of 84

56 i. size; and ii. type 7.13 Ligature Wire Systems i. number of ends; ii. tip type (e.g. ligature director, explorer, ligature applicator, ligature picker, ligature tucker, plugger, scaler, positive positioner, wire bender); and iii. handle type Lingual Attachments i. type (e.g. surgical hooks and attachments); and ii. sizes Orthodontic Brackets i. tooth type; ii. type (e.g. metal, ceramic, titanium bracket); iii. slot size (e.g ); iv. torque (e.g. 17,7,3,-1,-7); v. angulation; vi. rotation; vii. hook (e.g. with or without); viii. colour (e.g. silver); and ix. maxillary or mandibular. All Brackets offered shall include: x. ceramic brackets; xi. plastic brackets; xii. stainless steel brackets; and xiii. titanium brackets Orthodontic Cement / Resin Systems i. setting time; ii. colours; and iii. kit Orthodontic Cement / Resin Systems - Orthodontic Mixes i. setting time; ii. colours; and iii. kit Orthodontic Cement / Resin Systems - Associated Applicators Page 56 of 84

57 i. type; ii. length (mm); and iii. kit Orthodontic Elastics i. colours; ii. sizes (e.g. 6.35mm, 3.18mm); iii. strength (e.g. heavy) Orthodontic Storage Systems i. dimensions; and ii. colours Orthodontic Screws i. application (e.g. bionator, orthopaedic corrector, upper & lower Schwarz, lower sagittal); ii. housing length (e.g.15 mm) in mm; iii. mesial-distal length (e.g. 11 mm) in mm; iv. height (e.g. 3.5 mm) in mm; v. maximum expansion (e.g. 11 mm) in mm; and vi. one complete turn (e.g. 0.8 mm) in mm Photographic Camera i. picture resolution; and ii. sizes Pliers i. pliers type (e.g. Pin Cutter, Distal End Cutter, How, Band Removing, Tweed, V-Stop, 3-Step, Weingart, Rose Torquing); ii. tip shape (e.g. angled, curved, cylindrical, round, straight); iii. tip texture (e.g. serrated, smooth); iv. locking or non-locking; v. material; and vi. includes cutter (e.g. cutting or non-cutting) Retainer Boxes i. dimensions; and ii. colours Retraction Suction System i. sizes. Page 57 of 84

58 7.26 Thermoforming Material i. type; ii. sizes; and iii. heat specification Tongue Depressors i. sterile or non-sterile; and ii. overall length (mm) Wax Orthodontic i. orthodontic tray wax sticks or patient wax; ii. flavoured or unflavoured; and iii. colours Wire Cutters i. blade shape (e.g. angled, straight); ii. compatible cutting material; iii. cutter type (e.g. distal end); and iv. handle type (e.g. curved). Page 58 of 84

59 Category 8 - Preventative Products a A full range of dental Preventative products is required to meet clinical needs of products from subcategory 8.01 to 8.11 as per Appendix 1 Product List. This includes: i. a full range of sizes and configuration; ii. sterile and non-sterile; iii. single use (disposable) and re-usable; iv. brand name; v. manufacturer name; vi. type of material that product is made of; vii. international codes (e.g. ISO, colour, sizes); and viii. autoclave compatible or not autoclave compatible. b For each product offered in the subcategories below, Respondent must provide the following information in the Product Description on the Tender Response Worksheet: 8.01 Disclosing Products i. dispensing type (e.g. tablet, paste, gel); and ii. sizes Floss i. dispensing type (e.g. roll, box); ii. flavour (e.g. mint); iii. grit(e.g. waxed, non-waxed); iv. sizes (e.g. metre/spool); and v. thickness (e.g. ribbon, tape, string, super) Flouride Products Gels i. dispensing type (e.g. bottle); ii. flavour (e.g. mint, orange, berry); and iii. fluoride content % Flouride Products Varnishes i. dispensing type (e.g. paste, liquid); ii. flavour (e.g. mint); and iii. fluoride content % Flouride Products Foams i. dispensing type (e.g. bottle); ii. flavour; and iii. fluoride content %. Page 59 of 84

60 8.06 Flouride Products Flouride Trays i. type (e.g. single, double tray); ii. colours; and iii. sizes (e.g. Extra Small (Child), Small, Medium, Large) Mouth Guard Blanks i. type; ii. colours; and iii. sizes Prophy Brushes i. dispensing type (e.g. latch bristle); ii. style (e.g. flat or pointed); and iii. latex free Prophy Cups i. dispensing type (e.g. latch, screw, snap on); ii. style (e.g. firm or soft); and iii. latex free Prophy Paste i. flavour (e.g. spearmint, peppermint, citrus); ii. grit (e.g. polish, stain removal); iii. type (e.g. with or without fluoride); and iv. dosage (e.g. single dose or jar) Tooth Mousse i. dispensing type (e.g. tube); and ii. flavour (e.g. assorted). Page 60 of 84

61 Category 9 - Restorative Products a A full range of dental Restorative products is required to meet clinical needs of products from subcategory 9.01 to 9.39 as per Appendix 1 Product List. This includes: i. a full range of sizes and configuration; ii. sterile and non-sterile; iii. single use (disposable) and re-usable; iv. brand name; v. manufacturer name; vi. type of material that product is made of; vii. international codes (e.g. ISO, colour, sizes); and viii. autoclave compatible or not autoclave compatible. b For each product offered in the subcategories below, Respondent must provide the following information in the Product Description on the Tender Response Worksheet: 9.01 Caries Detectors i. colours (e.g. green, red); and ii. delivery (e.g. syringe, bottle) Cements / Liners Calcium Hydoxide (CaOH) Liners i. type of paste (e.g. CaOH, glass ionomer, adhesive); and ii. delivery system (e.g. tube, bottle, cartridge) Cements / Liners Glass Ionomer Cement (GIC) Cements i. type (e.g. glass ionomer, zinc oxide eugenol, zinc oxide; and ii. style (e.g. dual cure, self setting) Cements / Liners Resin Cements i. shade (e.g. universal, clear, blue); ii. style (e.g. light cure, self-cure, dual cure); and iii. delivery system (e.g. bottle) Composite Resin Bonding - Kits i. shade (e.g. A1, A2, B1, A02, A1/A2, A3.5); ii. style (e.g. light cure, self-cure, dual cure); and iii. delivery system (e.g. capsule, syringe) Core Build-Up i. shade (e.g. A2, tooth colour, radiopaque); ii. colour (e.g. natural); and Page 61 of 84

62 iii. style (e.g. light cure, self-cure, dual cure) Crowns Stainless Steel i. tooth type (e.g. first molar); ii. quadrant (e.g. lower left); iii. sizes (e.g. 00-6); and iv. deciduous or adult Filling Material - Amalgams i. set time (e.g. fast, regular set); ii. spill (e.g. 3 spill); and iii. delivery (e.g. capsule) 9.09 Filling Material Composites, Anterior i. shade (e.g. A1, A2, B1, A02, A3); ii. body (e.g. syringe); iii. viscosity (e.g. low, high flow); and iv. setting time (e.g. dual cure) Filling Material Composites, Posterior i. shade (e.g. A1, A2); ii. body (e.g. syringe); iii. viscosity (e.g. low, high flow); and iv. setting time (e.g. dual cure) Filling Material Composites, Flowable i. shade (e.g. A2, A1/A2); ii. body (e.g. syringe); iii. viscosity (e.g. low, high flow); and iv. setting time (e.g. dual cure) Filling Material Flow Dispensing Tips i. tip numeric size (e.g. 2ml (3.4g)); ii. shade; (e.g. black); and iii. filling material compatibility (e.g. G-aenial, wave, flowable) Filling Material Glass Ionomer Cement (GIC) - Self Cured i. type (e.g. capsule); ii. composition (e.g. glass ionomer); iii. shade (e.g. A1, A2);and iv. setting time (e.g. normal). Page 62 of 84

63 9.14 Filling Material Glass Ionomer Cement (GIC) - Light Cured i. type (e.g. capsule); ii. composition (e.g. glass ionomer); iii. shade (e.g. A1, A2); and iv. setting time (e.g. dual cure) Filling Material Resin Modified Glass Ionomer Cement (RMGIC) Filling i. type (e.g. capsule, powder/liquid); ii. shade (e.g. yellow A3); iii. composition (e.g. glass ionomer);and iv. setting time Finishing and Polishing Finishing Pastes i. type (e.g. paste); ii. delivery (e.g. syringe); iii. composition (e.g. diethylene glycol); and iv. grit (e.g. coarse, fine grit) Finishing and Polishing Finishing Strips i. type (e.g. metal); ii. composition; iii. material (e.g. aluminium oxide, metal); iv. thickness/width (e.g.1.9mm, 3.9mm); v. grit; and vi. colour Fissure Sealant i. type; ii. composition; iii. grit; iv. colour (e.g. opaque, clear); and v. delivery system Matrices and Wedges Matrix Bands, Sectional i. type of material (e.g. stainless steel); ii. shape of band (e.g. straight, curved, contoured); iii. thickness in mm; iv. gauge; v. sizes; and vi. non sterile Matrices and Wedges Matrix Bands, Siqveland i. type of material (e.g. stainless steel); ii. shape of band (e.g. straight, curved, contoured); Page 63 of 84

64 iii. thickness (mm); iv. gauge; v. sizes; and vi. non sterile Matrices and Wedges Matrix Bands, Retainerless Matrix System i. type of material (e.g. stainless steel); ii. shape of band (e.g. straight, curved, contoured); iii. thickness (mm); iv. gauge; v. size; and vi. non sterile Matrices and Wedges Matrix Bands, Tofflemire i. type of material (e.g. stainless steel); ii. shape of band (e.g. straight, curved, contoured); iii. thickness (mm); iv. gauge; v. sizes; and vi. non sterile Matrices and Wedges Matrix Retainers (Bands) i. type of material (e.g. stainless steel); ii. coverage / style (e.g. anterior, posterior); iii. sizes (mm); iv. thickness (mm); and v. matrix band compatibility Matrices and Wedges Matrix Retainers (Sectional) i. kits or replacement Matrices and Wedges Matrix Strips i. type of material (e.g. plastic); ii. sizes (mm); iii. thickness (mm); iv. colours; and v. delivery system Matrices and Wedges Wedges i. type of material (e.g. wood or plastic); ii. shape of wedges (e.g. anatomical, rounded); and iii. thickness (mm) Matrices and Wedges Cervical System Kit i. tooth type (e.g. molar/universal); ii. sizes; and Page 64 of 84

65 iii. colours Matrices and Wedges Cervical System Kit Refills i. tooth type (e.g. molar/universal); ii. sizes; and iii. colours Matrices and Wedges Sectional System Kit i. type of material (e.g. glass-fiber reinforced plastic nickel-titanium ring, spring steel); ii. items in each kit; iii. kit comprised of (e.g. rings, matrices, wedges, wedgeguards, forceps and pin tweezers); iv. coverage (e.g. posterior); and v. sizes (mm). Note: Supplier to supply sectional matrix bands compatibility 9.30 Matrices and Wedges Sectional System Kit Refills i. type of material (e.g. glass-fiber reinforced plastic nickel-titanium ring, spring steel); ii. items in each kit; iii. kit comprised of (e.g. rings, matrices, wedges, wedgeguards, forceps and pin tweezers); iv. coverage (e.g. posterior); and v. sizes (mm) Pins i. type of material (e.g. titanium, glass fibre); ii. length (e.g. short, standard, long) in mm; iii. sizes; and iv. mandrel Posts i. type of material (e.g. titanium, glass fibre); ii. length (e.g. short, standard, long) in mm; iii. size (mm); and iv. mandrel Resin Bonding System - Primer i. type; and ii. bonding system compatibility Resin Bonding System - Sealer i. type; ii. bonding system compatibility; and iii. style (e.g. light cure). Page 65 of 84

66 9.35 Resin Bonding System Etch i. type; ii. style (e.g. light cure, self-cure, dual cure); iii. percentage of etch; and iv. delivery system (e.g. syringe or bottle) Resin Bonding System Primer / Sealer combination i. type (e.g. self-etching) Resin Reinforcement Ribbon i. type; and ii. sizes (mm) Temporary Cement i. style (e.g. light cure, self-cure, dual cure); ii. eugenol or non-eugenol; and iii. delivery system Temporary Crown Forms i. shade; ii. tooth type; iii. tooth size; and iv. material. Page 66 of 84

67 Category 10 - Surgical Products a A full range of dental Surgical products is required to meet clinical needs of products from subcategory to as per Appendix 1 Product List. This includes: i. a full range of sizes and configuration; ii. sterile and non-sterile; iii. single use (disposable) and re-usable; iv. brand name; v. manufacturer name; vi. type of material that product is made of; vii. international codes (e.g. ISO, colour, sizes); and viii. autoclave compatible or not autoclave compatible. b For each product offered in the subcategories below, Respondent must provide the following information in the Product Description on the Tender Response Worksheet: Bone Files i. number of ends (e.g. single, double); ii. handle type; iii. tip type (e.g. Miller-Colburn); and iv. tip material (e.g. carbon steel, stainless steel) Bone Trimmers i. number of ends (e.g. double, single); ii. tip type; iii. handle type; and iv. tip material Elevators i. elevator type (e.g. surgical); ii. number of ends (e.g. single, double); iii. tip type (e.g. cryer); iv. tip texture (e.g. serrated, smooth); v. tip material; vi. handle material; vii. handle type; viii. handle shape; and ix. blade orientation (e.g. left, right, straight, curved) Forceps i. extraction application (e.g. lower first molar); ii. handle material; iii. beak type (e.g. cowhorn); and iv. deciduous or permanent. Page 67 of 84

68 10.05 Haemostats i. tip type (e.g. straight, curve); and ii. handle material Luxators i. handle shape; ii. number of ends; iii. handle material; iv. handle type; v. tip type (e.g. curved, straight); vi. blade orientation; vii. elevator type (e.g. luxating); viii. tip texture (e.g. flat or serrated); ix. tip length (mm); and x. tip width. Page 68 of 84

69 E Appendices E Appendices Appendix 1 - Product List Category Subcategories 1 BURS 1.01 BURS DIAMOND FINISHING AND POLISHING BURS DIAMOND RESTORATIVE BURS STEEL RESTORATIVE BURS STEEL SURGICAL BURS STEEL ACRYLIC STAINLESS STEEL 1.06 BURS TUNGSTEN CARBIDE FINISHING AND POLISHING 1.07 BURS TUNGSTEN CARBIDE RESTORATIVE BURS TUNGSTEN CARBIDE SURGICAL BUR STANDS MANDRELS POLISHING DISCS 2 ENDODONTIC PRODUCTS BLEACHING MATERIAL BROACHES BARBED 2.03 BROACHES SMOOTH 2.04 CEMENTS & SEALERS Page 69 of 84

70 E Appendices Category Subcategories DRILLS GATES GLIDDEN DRILLS PEESO DRILLS FILLERS AND SPIRALS FILES - HAND FILES - PATHFINDERS FILES - REAMERS FILES - ROTARY FINGER PLUGGERS AND SPREADERS GAUGES AND RULERS IRRIGATION SOLUTIONS MEDICAMENTS POINTS GP POINTS PAPER POST ENDODONTICS BLEACHING PRODUCTS RINGS & STOPPERS STORAGE ACCESSORIES TEMPORARY FILLING AIR WATER SYRINGE TIPS Page 70 of 84

71 E Appendices Category Subcategories 3 GENERAL CONSUMABLES ANAESTHETICS NEEDLES APPLICATOR, ONE-PIECE MICRO- BRUSHES 3.04 APPLICATOR, ONE-PIECE MULTI- BRUSHES 3.05 ARTICULATING - PAPERS 3.06 ASPIRATOR TUBE - DISPOSABLE 3.07 BARRIERS AND DRAPES PRODUCTS 3.08 BIBS 3.09 BIB CHAINS COTTON PRODUCTS - COTTON GUARDS COTTON PRODUCTS - COTTON HAEMOSTAT & PLEDGETS 3.12 COTTON PRODUCTS - COTTON PELLETS 3.13 COTTON PRODUCTS - COTTON ROLLS DAPPEN DISHES DENTAL IMPRESSION SOLUTION - DISINFECTION MATERIAL 3.16 DENTAL WATER-UNIT TREATMENT - TABLETS 3.17 DISPOSABLE HOLDERS- WELLs 3.18 DISTILLED WATER 3.19 GINGIVAL RETRACTION CORDS Page 71 of 84

72 E Appendices Category Subcategories 3.20 GINGIVAL RETRACTION HAEMOSTATIC SOLUTIONS HAEMOSTATIC SPONGES MIXING PAD FOR IMPRESSION & RESTORATIVE MATERIAL RUBBER DAM SHEETS RUBBER DAM ACCESSORIES INTERPROXIMAL ELASTIC STABILISER 3.25 SALIVA EJECTORS 3.26 SUCTION TUBE ADAPTOR 3.27 SUCTION TUBE, SINGLE USE 4 IMPRESSION PRODUCTS BITE REGISTRATION - SILICONE BITE REGISTRATION - WAX 4.03 DENTURE PRESSURE INDICATOR PASTE 4.04 IMPRESSION ADHESIVES 4.05 IMPRESSION DISPENSING TOOLS IMPRESSION TRAY CLEANERS MATERIALS IMPRESSION ADDITION SILICONE 4.08 MATERIALS IMPRESSION ALGINATE MATERIALS IMPRESSION POLYETHER MATERIALS IMPRESSION POLYVINYL SILAXANE Page 72 of 84

73 E Appendices Category Subcategories 4.11 MATERIALS IMPRESSION ZINC OXIDE EUGENOL (ZOE) 4.12 SPATULAS 4.13 TRAYS METAL 4.14 TRAYS SINGLE USE, DISPOSABLE 5 INSTRUMENTS AND ACCESSORIES AMALGAM CARRIERS APPLICATOR INSTRUMENTS 5.03 ARTICULATING PAPER HOLDER 5.04 ASPIRATING SYRINGES 5.05 COMPOSITE GUN 5.06 COMPOSITE INSTRUMENTS 5.07 CORD PACKERS 5.08 CRIMPING PLIERS 5.09 CROWN REMOVERS 5.10 CURETTES 5.11 FRACTURE FINDERS 5.12 GIC APPLICATOR GUN GIC ACTIVATOR INSTRUMENT ACCESSORIES CASSETTES Page 73 of 84

74 E Appendices Category Subcategories 5.15 INSTRUMENT ACCESSORIES INSTRUMENT TRAYS 5.16 INSTRUMENT ACCESSORIES INSTRUMENT SHARPENERS 5.17 INSTRUMENT PREPARATION BURNISHERS INSTRUMENT PREPARATION - CARVERS INSTRUMENT PREPARATION - CHISELS INSTRUMENT PREPARATION - EXCAVATORS 5.21 INSTRUMENT PREPARATION - EXPLORERS 5.22 INSTRUMENT PREPARATION - PERIODONTAL PROBE INSTRUMENT PREPARATION - HATCHETS INSTRUMENT PREPARATION - MARGIN TRIMMERS 5.25 INSTRUMENT PREPARATION - PLASTIC INSTRUMENT INTRALIGAMENTARY SYRINGES MIRRORS MIRROR ACCESSORIES - HANDLE MOUTH PROPS NEEDLE HOLDERS PACKERS AND PLUGGERS Page 74 of 84

75 E Appendices Category Subcategories 5.32 RETRACTORS - CHEEK 5.33 RETRACTORS - LIP 5.34 RETRACTORS - TONGUE 5.35 RUBBER DAM CLAMPS RUBBER DAM - FRAMES SAFETY SYRINGE SYSTEM, LOCAL ANAESTHETICS 5.38 SCALERS 5.39 SCISSORS 5.40 TWEEZERS 6 LABORATORY PRODUCTS ACRYLIC RESIN COLD CURE ACRYLIC RESIN HEAT CURE 6.03 BLEACHING BLEACHING TRAYS 6.04 BLEACHING GINGIVAL BARRIERS 6.05 CASTING & INVESTING CRUCIBLES CASTING & INVESTING INVESTMENTS CASTING & INVESTING NON-PRECIOUS ALLOY 6.08 CASTING & INVESTING SEMI-PRECIOUS ALLOY 6.09 CASTING & INVESTING PRECIOUS ALLOY Page 75 of 84

76 E Appendices Category Subcategories CASTING & INVESTING SOLDER CASTING & INVESTING LAB PUTTY CERAMICS & COMPOSITES INDIRECT COMPOSITES 6.13 CERAMICS & COMPOSITES MACHINABLE CERAMICS CERAMICS & COMPOSITES CERAMICS DENTAL COMPOUND CAKE DENTAL COMPOUND STICK DENTAL PLASTERS DENTAL STONES FINISHING & POLISHING FINISHING MOPS 6.20 FINISHING & POLISHING FINISHING POLISH / PASTE 6.21 FINISHING & POLISHING FINISHING PUMICE 6.22 FINISHING & POLISHING SANDBLASTING MATERIALS INVESTMENT ACCESSORIES MODEL FABRICATION DUPLICATING MATERIAL MODEL FABRICATION GYPSUMS MODEL FABRICATION MODEL PREPARATION Page 76 of 84

77 E Appendices Category Subcategories 6.27 MODEL FABRICATION PIN / MODEL SYSTEMS MODEL FABRICATION SAW BLADES MODEL FABRICATION SEPARATORS PLASTER CUTTERS POLISHERS BRUSHES POLISHERS BUFFS PREFORMED PATTERS PREFORMED WAX PATTERNS 6.34 PROSTHETICS CHARACTERISATION KITS PROSTHETICS SEPARATING AGENTS PROSTHETICS TEETH PUTTIES & SILICONES GINGIVAL SILICONE SOFT RELINING MATERIAL - TEMPORARY SOFT RELINING MATERIAL - PERMANENT WAX BASEPLATE WAX BOXING WAX CARVING WAX CASTING SHEET WAX DIPPING Page 77 of 84

78 E Appendices Category Subcategories 6.45 WAX INLAYS 6.46 WAX PERIPHERY 6.47 WAX SPRUES 6.48 WAX STICKY 7 ORTHODONTIC PRODUCTS WAXING INSTRUMENTS ARCH WIRE, COMPONENTS AND ATTACHMENTS BANDING SYSTEMS BUCCAL TUBES CEPHALOMETRIC ACCESSORIES - MARKING INSTRUMENTS 7.05 CEPHALOMETRIC ACCESSORIES - MEASURING INSTRUMENTS 7.06 COIL SPRING 7.07 DISC GUARD 7.08 DOUBLE SIDED STRIPPING DISC 7.09 FACEBOWS 7.10 FORCEPS ORTHODONTIC 7.11 HEADGEAR SYSTEMS AND ORAL SCREEN 7.12 INTRAORAL MIRROR 7.13 LIGATURE WIRE SYSTEMS Page 78 of 84

79 E Appendices Category Subcategories 7.14 LINGUAL ATTACHMENTS 7.15 ORTHODONTIC BRACKETS ORTHODONTIC CEMENT / RESIN SYSTEMS ORTHODONTIC CEMENT / RESIN SYSTEMS ORTHODONTIC MIXES 7.18 ORTHODONTIC CEMENT / RESIN SYSTEMS ASSOCIATED APPLICATORS 7.19 ORTHODONTIC ELASTICS 7.20 ORTHODONTIC STORAGE SYSTEMS 7.21 ORTHODONTIC SCREWS 7.22 PHOTOGRAPHIC CAMERA 7.23 PLIERS 7.24 RETAINER BOXES 7.25 RETRACTION SUCTION SYSTEM 7.26 THERMOFORMING MATERIAL 7.27 TONGUE DEPRESSORS 7.28 WAX - ORTHODONTIC 7.29 WIRE CUTTERS 8 PREVENTATIVE PRODUCTS DISCLOSING PRODUCTS FLOSS Page 79 of 84

80 E Appendices Category Subcategories 8.03 FLUORIDE PRODUCTS GELS 8.04 FLUORIDE PRODUCTS VARNISHES FLUORIDE PRODUCTS FOAMS FLUORIDE PRODUCTS FLUORIDE TRAYS 8.07 MOUTH GUARD BLANKS 8.08 PROPHY BRUSHES 8.09 PROPHY CUPS 8.10 PROPHY PASTE 8.11 TOOTH MOUSSE 9 RESTORATIVE PRODUCTS CARIES DETECTORS CEMENTS / LINERS CALCIUM HYDROXIDE (CAOH) LINERS 9.03 CEMENTS / LINERS GLASS IONOMER CEMENT (GIC) CEMENTS 9.04 CEMENTS / LINERS RESIN CEMENTS 9.05 COMPOSITE RESIN BONDING KITS 9.06 CORE BUILD-UP 9.07 CROWNS - STAINLESS STEEL FILLING MATERIALS AMALGAMS FILLING MATERIALS COMPOSITES, ANTERIOR Page 80 of 84

81 E Appendices Category Subcategories 9.10 FILLING MATERIALS COMPOSITES, POSTERIOR 9.11 FILLING MATERIALS COMPOSITES, FLOWABLE 9.12 FILLING MATERIALS FLOW DISPENSING TIPS 9.13 FILLING MATERIALS GLASS IONOMER CEMENT (GIC) SELF CURED 9.14 FILLING MATERIALS GLASS IONOMER CEMENT (GIC) LIGHT CURED 9.15 FILLING MATERIALS RESIN MODIFIED GLASS IONOMER CEMENT (RMGIC) FILLING 9.16 FINISHING & POLISHING FINISHING PASTES 9.17 FINISHING & POLISHING FINISHING STRIPS FISSURE SEALANT MATRICES & WEDGES MATRIX BANDS, SECTIONAL 9.20 MATRICES & WEDGES MATRIX BANDS, SIQVELAND 9.21 MATRICES & WEDGES MATRIX BANDS, RETAINERLESS MATRIX SYSTEM 9.22 MATRICES & WEDGES MATRIX BANDS, TOFFLEMIRE 9.23 MATRICES & WEDGES MATRIX RETAINERS (BANDS) 9.24 MATRICES & WEDGES MATRIX RETAINERS (SECTIONAL) 9.25 MATRICES & WEDGES MATRIX STRIPS Page 81 of 84

82 E Appendices Category Subcategories MATRICES & WEDGES WEDGES MATRICES & WEDGES CERVICAL SYSTEM KIT 9.28 MATRICES & WEDGES CERVICAL SYSTEM KIT REFILLS 9.29 MATRICES & WEDGES SECTIONAL SYSTEM KIT 9.30 MATRICES & WEDGES SECTIONAL SYSTEM KIT REFILLS PINS POSTS RESIN BONDING SYSTEM PRIMER RESIN BONDING SYSTEM SEALER RESIN BONDING SYSTEM ETCH RESIN BONDING SYSTEM PRIMER / SEALER COMBINATION SURGICAL PRODUCTS RESIN REINFORCEMENT RIBBON TEMPORARY CEMENT TEMPORARY CROWN FORMS BONE FILES BONE TRIMMERS ELEVATORS FORCEPS Page 82 of 84

83 E Appendices Category Subcategories HAEMOSTATS LUXATORS Page 83 of 84

84 E Appendices Appendix 2 - References A 2.a Standards The references to the below standards include any amendments, revisions or consolidations to those standards. For each standard listed, Respondent are to ensure the latest publication of each standard is used. Standard Number Standard Name AS/NZS 4187 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities National Standard 3 Preventing and Controlling Healthcare Associated Infections AS National Safety and Quality Health Service Standards (NSQHSS) by Australian Commission on Safety and Quality in Health Care (ACSQHC). Packaging of items (sterile) for patient care. Part 4: Flexible Packaging Systems for single use in hospitals. ISO ISO 7864 / AS 1946 Medical Devices Quality Management System. Sterile hypodermic needles for single use. A 2.b Guidelines and Other References The references to the below guidelines include any amendments, revisions or consolidations to those guidelines. NHMRC (2010), Australian Guidelines for the Prevention and Control of Infection in Healthcare, Commonwealth of Australia Therapeutic Goods Administration (1991), Therapeutic Goods Order No. 37: General Requirements for Labels for Therapeutic Goods Therapeutic Goods Administration (2004), Uniform Recall Procedure for Therapeutic Goods, Commonwealth of Australia. Therapeutic Goods Administration (2011), Australian Regulatory Guidelines for Medical Devices. Page 84 of 84