Procedure and Laboratory Manual For Cagenix AccuFrame System

Transcription

1 Procedure and Laboratory Manual For Cagenix AccuFrame System Version 2.0 August 2009

2 Cagenix AccuFrame Procedure and Laboratory Manual The Cagenix AccuFrame is an implant framework and acts as a superstructure for a multiple implant-based prosthesis. The AccuFrame is designed for a specific patient using CAD software and is milled out of a single piece of titanium alloy. Through the utilization of CAD/CAM technology, we are able to fabricate this dental implant framework with an unsurpassed fit in comparison to traditional casting processes. In the virtual CAD environment, Cagenix can quickly and easily design an AccuFrame for any patient. The single-piece fabrication process allows for a superior strength compared to cast or soldered/welded frameworks. Cagenix is enabling labs of any size to offer this technology to their customers with the introduction of the Cagenix AccuFrame. Advantages to the Dentist Improves fit. Reduces delivery time of the final prosthesis. Eliminates secondary processes: cutting and soldering/welding, thereby reducing delivery time of the final prosthesis. Reduces visits per patient. Made with a stronger material than gold/precious alloys. Compatible with multiple implant systems, even within a single prosthesis. Advantages to the Dental Laboratory Improves initial fit, thus eliminating secondary processes and remakes. Provides significant time savings in laboratory labor. Reduces inventory for necessary materials (e.g. gold alloy) and implant components. No capital investment for scanner, software, articulators, and/or laser welding unit. Eliminates casting of the alloys. More efficient utilization of highly trained technicians. Stability of material cost: titanium alloy versus gold alloy. Reduces cost of materials (e.g. gold alloy), parts, and implant components. Compatible with multiple implant systems, even within a single prosthesis. Advantages to the Patient Improves turnaround time for delivery of final prosthesis. Reduces number of visits, cost and time savings. Each AccuFrame is custom designed for optimal aesthetics and function. Compatible with multiple implant systems, even within a single prosthesis. Made with a stronger material than gold/precious alloys. Version 2.0 August 2009

3 Table Of Contents References Cited 1 Order Form Instructions 2 Laboratory Procedures 5 Cagenix AccuFrame Design Parameters 8 Companies and Connections Supported 9 Appropriate Impression Copings and Analogs for Cagenix AccuFrame 10 Impression Procedures 13 Creation of a Verification Index 30 Lab Processing/Framework Veneering 31 Final Fixation 32 Description of AccuFrame Bar and Framework Profiles 33 Notices 37 Version 2.0 August 2009

4 References Cited The Cagenix AccuFrame Procedure and Laboratory Manual has cited the following Implant Manufacturer Catalogs in referencing all catalog numbers and part descriptions. Implant Manufacturers Catalog Astra Tech Astra Tech Dental Product Catalog 2007 Biomet 3i Product Catalog Restorative Technologies REV A 08/08 HIOSSEN HIOSSEN HS System Catalog (online) Keystone (Stage-1 ) Lifecore Dental Stage-1 Implant System US Catalog (2006) MIS MIS Product Catalog 2008 Neoss Neoss Product Catalog 2008 Nobel Biocare Nobel Biocare NobelEsthetics & Procera Catalog (2007) Straumann Straumann Product Catalog 2008 Sybron SybronPRO Series Product Catalog 2008 Thommen Thommen Medical SPI System Product Catalogue June 2008 Zimmer Product Catalog Rev 03/09 Version 2.0 August of 37

5 Order Form Instructions The Order Form supplies Cagenix with the necessary information regarding the customer and design considerations for the case and must be filled out before an AccuFrame can be designed and manufactured. Dental Laboratory and Patient Information In this section of the order form, the dentist or dental laboratory will fill out all of the pertinent contact information as well as supply information regarding the patient s identification. If the dentist/dental laboratory would prefer to not release any information regarding the patient, a patient case number can be disclosed rather than providing the name of the patient. This section also provides areas for the customer to provide additional contacts, billing information, delivery options and the date of the patient s next scheduled visit. In addition, there is an area where the customer can request a Design Approval. This Design Approval will be sent to the customer via with various images of the framework as it has been designed. The customer will be able to review the attached images and send any modifications to be included in the design of the AccuFrame before milling. Version 2.0 August of 37

6 In the next section there is a list of important notices and items that need to be included if an AccuFrame is to be designed correctly. The dentist or dental laboratory denotes the location of the implants in the patient s mouth, the implant analog and abutment manufacturer, and the model/catalog number. The dental laboratory technician or dentist must utilize the appropriate analog for supported implants and abutments. If the improper analogs have been placed in the master stone cast, the case will be returned to the customer. The dentist or dental laboratory can choose the profile of the framework or bar to be designed into their AccuFrame and provide directions regarding the distal extensions and the space between the framework/bar and the tissue. Version 2.0 August of 37

7 In the final section the dentist or dental laboratory is able to give a list of instructions for the design of their AccuFrame. A checklist is provided for the included items sent by the customer for the design and fabrication of the AccuFrame. Finally, a signature line is provided that signifies the customer s authorization for Cagenix to design and fabricate an AccuFrame to their specifications fitting the master stone cast that they have sent. The signature also confirms that the master stone cast is accurate and has been verified by both the dental technician and dentist. Version 2.0 August of 37

8 Laboratory Procedures 1. Create impression using appropriate impression transfer components as per implant manufacturer s specifications. It is important for the dentist to make an impression utilizing the appropriate impression copings/transfers for the supported implant systems as listed in this manual. Cagenix recommends using a rigid impression material such as a polyether impression material (for example Impregum Penta by 3M ESPE) along with the associated tray adhesive. Follow the directions as specified by the material manufacturer. 2. Fabricate a master stone cast using the appropriate analogs. (Ensure 1 mm clearance around analogs.) A master stone cast of the impression will be created utilizing the appropriate analogs, as listed in this manual. Cagenix recommends making a master stone cast utilizing a gypsum or die stone material such as ResinRock (Whip Mix Corporation). Attach the analogs to the impression copings/transfers as directed by the implant manufacturer and pour up the impression. Allow the stone cast to fully harden before removing and then check the master stone cast for accuracy. Remove approximately 1 mm of the stone material around the shoulder of the analogs to allow for clearance/fit of the framework. If 1 mm of clearance cannot be achieved, we recommend the creation of a Soft Tissue Cast. In order to ensure the accuracy of the stone model, Cagenix recommends a verification index be created which will assess the placement of the analogs in the stone cast with the implants and abutments placed in the patient s mouth. Please review the Verification Index portion of the manual for further details. Version 2.0 August of 37

9 Version 1.4 June Produce a diagnostic wax up of the proposed dentition, taking into consideration the placement of the implants relative to the opposing dentition. 4. Complete order form with all pertinent information and specific instructions for the design of the AccuFrame. 5. Securely package all contents (master stone cast, diagnostic wax up, and order form) into a box and send to: Cagenix 795 Ridge Lake Blvd. Suite 107 Memphis,TN Steps for the Design of the Cagenix AccuFrame Digital point clouds are created of the master stone cast and diagnostic wax up. A digital CAD file of the AccuFrame is designed to the dental laboratory s instructions. If a Design Approval is requested, pictures of the digitally designed AccuFrame will be sent to the customer s to be approved. Point Cloud of the Stone Cast and Digital AccuFrame Digital AccuFrame designed according to point cloud data from Stone Cast and Diagnostic Wax Up Version 2.0 August of 37

10 6. Review the images enclosed in the Design Approval and respond with any necessary design changes. Each customer can denote on the order form whether they would like to receive a Design Approval for their AccuFrame order. Each customer will be able to review the images and respond with any necessary changes in regard to the design of the AccuFrame. The AccuFrame will be fabricated upon receipt of the Design Approval and according to the original file or to the noted changes disclosed during this review time. The pictures shown in step 5 are representative of the pictures the customer will receive. Steps for the Manufacture of the Cagenix AccuFrame The digital AccuFrame file is sent to a multi-axis milling machine to be manufactured and inspected for quality control, ensuring an accurately fitting framework to the stone. Upon completion of inspection, the AccuFrame is delivered to the customer for the prosthesis to be finalized. Version 2.0 August of 37

11 Cagenix AccuFrame Design Parameters Dimension Removable Prosthesis Fixed Prosthesis Min. Max. Min. Max. Platform Diameter 3.0 mm 6.0 mm 3.0 mm 6.0 mm Cylinder Height 2.5 mm 10.0 mm 2.5 mm 10.0 mm Maximum Angulations Between Cylinders (Per manufacturer s specification) 0.0⁰ 30.0⁰ 0.0⁰ 30.0⁰ Total Implants or Abutments Bar Span between Implants or Abutments (from outside surface of cylinders) 2.0 mm 18.0 mm 2.0 mm 18.0 mm Bar Height 2.0 mm 10.0 mm 2.0 mm 10.0 mm Bar Width 1.8 mm 10.0 mm 4.0 mm 10.0 mm Total Height 2.0 mm 10.0 mm 2.0 mm 10.0 mm Anterior/Posterior Spread 0.0 mm 60.0 mm 0.0 mm 60.0 mm Distal Extension 0.0 mm 12.0 mm 0.0 mm 12.0 mm Angulations between Bar and Cylinder 0.0⁰ 20.0⁰ 0.0⁰ 20.0⁰ These Design Parameters are those that have been tested and approved for use with the Cagenix AccuFrame. It is possible for Cagenix to create a frame that falls outside of these parameters. However, such a framework is subject to additional costs and will require the customer to sign a Liability Release Form to enable Cagenix to manufacture the AccuFrame. All Orders that exceed these Design Parameters will require an analysis as to its feasibility and also include premium pricing to cover any additional costs in manufacturing. Version 2.0 August of 37

12 Companies and Connections Supported Companies Connections Astra Tech Dental Biomet 3i HIOSSEN HS System Keystone (Stage-1 ) MIS Neoss Nobel Biocare Straumann Sybron 20 UniAbutment 45 UniAbutment IOL Abutment Conical Abutment (Emergence Profile 3.4, 5.0 and 6.0 mm) External Hex Implant (3.4, 4.1 and 5.0 mm) Octa Abutment (RP 4.8 mm) Indexed Abutment System (RDS and WDS) TransOcta Abutment (4.8 mm only) Implant Level Neoss Access Abutment Multi-Unit Abutment NobelReplace System Brånemark System Includes Multi-Unit Angled Abutments (must use analog 31161) Brånemark Systems External Hex Implant NP, RP, and WP Soft Tissue Level SynOcta Screw Retained (RN and WN) Bone Level Multi-Base Abutment (NC and RC) Octa Abutment (RN Only) Thommen SPI VARIOmulti Abutment (3.5, 4.0, 4.5, and 5.0 mm PF Ø) Zimmer Tapered Abutment Version 2.0 August of 37

13 Appropriate Impression Copings and Analogs for Cagenix AccuFrame It is important for the customer to utilize the appropriate impression copings/transfers and analogs associated with the manufacturers that we support. If a stone cast is sent without the appropriate analogs, Cagenix will be unable to process the order and it will be returned to the customer. Implant Manufacturer Impression Coping/Transfer Catalog Number Astra Tech Biomet 3i (20 UniAbutment Pickup 4.3 Ø mm) (20 UniAbutment Pickup 5.5 Ø mm) (45 UniAbutment Pickup 4.3 Ø mm) (45 UniAbutment Pickup 5.5 Ø mm) (20 /45 UniAbutment Transfer) (IOL) IOLPIC (IOL Pick-Up Impression Coping) IOLTIC (IOL Twist Lock Impression Coping) (Conical) MEC33 (Conical Abutment Pick-Up Impression Coping, 3.4 mm Seating Surface, 3.8 mm Emergence Profile) CSQI7 (Conical Abutment Pick-Up Impression Coping, 4.1 or 5 mm Seating Surface, 5 mm Emergence Profile) CSQ06 (Conical Abutment Pick-Up Impression Coping, 4.1 or 5 mm Seating Surface, 6 mm Emergence Profile) CSQ07 (Conical Abutment Pick-Up Impression Coping, 4.1 or 5 mm Seating Surface, 7.5 mm Emergence Profile) WCP662 (Conical Abutment Pick-Up Impression Coping, 6 mm Seating Surface, 6 mm Emergence Profile) CIC55 (Conical Abutment Twist Lock impression Coping, 4.1 or 5 mm Seating Profile, 5 mm Emergence Profile) CIC56 (Conical Abutment Twist Lock Impression Coping, 4.1 or 5 mm Seating Profile, 6 mm Emergence Profile) CIC57 (Conical Abutment Twist Lock Impression Coping, 4.1 or 5 mm Seating Profile, 7.5 mm Emergence Profile) WCT662 (Conical Abutment Twist Lock Impression Coping, 6 mm Seating Profile, 6 mm Emergence Profile) WCT672 (Conical Abutment Twist Lock Impression Coping, 6 mm Seating Profile, 6 mm Emergence Profile) Version 2.0 August of 37

14 Implant Manufacturer Impression Coping/Transfer Catalog Number Biomet 3i (External Hex) MIC33 (External Hex Pick-Up Impression Coping 3.4 mm Seating Surface, 3.8 mm Emergence Profile) IIC12 (External Hex Pick-Up Impression Coping 4.1 mm Seating Surface, 5 mm Emergence Profile) IIC60 (External Hex Pick-Up Impression Coping 4.1 mm Seating Surface, 6 mm Emergence Profile) IIC75 (External Hex Pick-Up Impression Coping 4.1 mm Seating Surface, 7.5 mm Emergence Profile) WIP55 (External Hex Pick-Up Impression Coping 5 mm Seating Surface, 5 mm Emergence Profile) WIP56 (External Hex Pick-Up Impression Coping 5 mm Seating Surface, 6 mm Emergence Profile) WIP57 (External Hex Pick-Up Impression Coping 5 mm Seating Surface, 7.5 mm Emergence Profile) IIC45 (External Hex Twist Lock Impression Coping 4.1 mm Seating Surface, 5 mm Emergence Profile) IIC46 (External Hex Twist Lock Impression Coping 4.1 mm Seating Surface, 6 mm Emergence Profile) IIC47 (External Hex Twist Lock Impression Coping 4.1 mm Seating Surface, 7.5 mm Emergence Profile) WIT55 (External Hex Twist Lock Impression Coping 5 mm Seating Surface, 5 mm Emergence Profile) WIT56 (External Hex Twist Lock Impression Coping 5 mm Seating Surface, 6 mm Emergence Profile) WIT57 (External Hex Twist Lock Impression Coping 5 mm Seating Surface, 7.5 mm Emergence Profile) HIOSSEN HSFPI48RO (Fixture Pick-up Impression Coping Octa) HSFPI48RN (Fixture Pick-up Impression Coping Non-Octa) HSFTI4809RN (Fixture Transfer Impression Coping One Piece, 9.5 mm) HSFTI4812RN (Fixture Transfer Impression Coping One Piece, 12.5 mm) HSFTI4809RO (Fixture Transfer Impression Coping Two Piece, 9.5 mm) HSFTI4812RO (Fixture Transfer Impression Coping Two Piece, 12.5 mm) Keystone (Stage-1 ) Please see Impression Technique Section for Lifecore (Stage 1) Cement On Crown Abutment with Appropriate Cement On Crown (COC) Quick Cap Version 2.0 August of 37

15 Implant Manufacturer Impression Coping/Transfer Catalog Number MIS Neoss CD-I0480 (Mistral Direct Impression Coping for Open Tray, Fixture Level) (Impression Coping 8 mm and Replica for Implant Level) (Impression Coping 11 mm and Replica for Implant Level) (Impression Coping 18 mm and Replica for Implant Level) (Neoss Access Impression Coping 8 mm and Replica ) Nobel Biocare (Multi-Unit) (Impression Coping Closed Tray Multi-unit 8 mm) (Impression Coping Bar Closed Tray Multi-unit 5 mm) (Impression Coping Open Tray Multi Unit) (Brånemark Systems ) (Branemark System NP Impression Coping Open Tray) (Branemark System RP Impression Coping Open Tray) (Branemark System WP Impression Coping Open Tray) (Branemark System NP Impression Coping Closed Tray) (Branemark System RP Impression Coping Closed Tray) (Branemark System WP Impression Coping Closed Tray) Straumann (Soft Tissue Level) (Bone Level) Sybron Thommen Zimmer (RN synocta Impression Cap) (RN synocta Impression Cap) (WN synocta Impression Cap) (NC 3.5 mm Diameter Impression Post) (NC 4.5 mm Diameter Impression Post) (RC 4.5 mm Diameter Impression Post) (RC 6.5 mm Diameter Impression Post) (NC 3.5 mm Diameter Impression Cap) (NC 4.5 mm Diameter Impression Cap) (RC 4.5 mm Diameter Impression Cap) (RC 6.5 mm Diameter Impression Cap) 5X142 (Implant Impression Coping) (VARIOmulti Impression Coping) ACTDT (Tapered Abutment Direct Transfer, Open-Tray) ACTIT (Tapered Abutment Indirect Transfer, Closed-Tray Version 2.0 August of 37

16 Impression Procedures Astra (UniAbutments), Biomet 3i (IOL and Conical), Neoss (Access), Nobel Biocare (Multi-Unit), Thommen (SPI VARIO), and Zimmer (Tapered) It is important for the above mentioned connections, that the dentist torques the abutments into place before making the impression. If the abutments are not torqued into place at the time of the impression, an inaccurate transfer of the implant/abutment position can occur resulting in an inaccurate stone cast. After the impression has been taken with the appropriate impression copings/transfers, it is recommended that the abutments remain attached to the implants and the dentist temporize the abutments in the patient s mouth. Straumann (Soft Tissue Level), Sybron, HIOSSEN, MIS For the Straumann Soft Tissue Level Implant, Sybron, HIOSSEN and MIS it is important that a fixture level impression is taken. Stone Casts with an abutment level analog cannot be processed by Cagenix. Keystone (Stage-1 ) Keystone does not make an impression transfer/coping for a fixture level impression, due to the lack of an indexing hex or octagon in the internal connection of the Stage-1 Implant System. Keystone does make fixture level analogs (S2436 and S2505) for the system for preparing an abutment. In order to create a fixture level impression for the Stage-1 Implant System, the dentist must use the Cement On Crown (COC) Abutments in combination with the Appropriate Quick Cap as an impression transfer. COC Abutments are hand-tightened onto the implants and the appropriate Quick Caps are placed on top of them. Once the impression has been made, the COC Abutments are removed from the implants, attached to the fixture level analogs (S2436 and S2505), and indexed back to the impression. A stone cast can now be generated with the fixture level analogs. The purpose of this impression technique is to capture the appropriate height and angulations of the implant fixture. Timing is not an issue since the flats of the abutments will not be engaged by the AccuFrame. IMPORTANT NOTE- Do not torque the abutments into place for the Keystone Stage 1 System. Hand-tighten the COC abutments to a firm fit, so they can be removed from the implants after the impression has been taken. Version 2.0 August of 37

17 Appropriate List of Analogs Implant Manufacturer Analog/Abutment Replica Catalog Number Astra Tech Biomet 3i (IOL) (Conical) (External Hex) HIOSSEN Keystone (Stage-1 ) MIS Neoss (20 UniAbutment Replica) (45 Uniabutment Replica) IOLLAS (IOL Abutment Laboratory Analog) MMCLA (3.4 mm Conical Abutment Laboratory Analog) CLA20 (5 mm Conical Abutment Laboratory Analog) WCLA6 (6 mm Conical Abutment Laboratory Analog) MMILA (3.4 mm External Hex Implant Laboratory Analog) ILA20 (4.1 mm External Hex Implant Laboratory Analog) ILAW5 (5 mm External Hex Implant Laboratory Analog) HSFLA48R (Fixture Lab Analog) S2436 (RDS Implant Analog) S2505 (WDS Implant Analog) CD-RSM48 (Mistral Implant Analog) (Impression Coping 8 mm and Replica for Implant Level) (Impression Coping 11 mm and Replica for Implant Level) (Impression Coping 18 mm and Replica for Implant Level) (Neoss Access Impression Coping 8 mm and Replica) Nobel Biocare (Multi-Unit) (Brånemark Systems ) Straumann (Soft Tissue Level) (Bone Level) Sybron Thommen Zimmer (Multi-Unit Abutment Replica) (Branemark System NP Implant Replica) (Branemark System RP Implant Replica) (Branemark System WP Implant Replica) (RN synocta Analog) (WN synocta Analog) (NC 3.5 mm Diameter Implant Analog) (NC 4.5 mm Diameter Implant Analog) (RC 4.5 mm Diameter Implant Analog) (RC 6.5 mm Diameter Implant Analog) 5X-140 (Implant Analog) (VARIOmulti Analog)Zimmer ACTR (Tapered Abutment Replica) Version 2.0 August of 37

18 Astra Flow Chart for Astra UniAbutments Impression Copings and Analogs to be used with AccuFrame System 20 and 45 UniAbutments UniAbutment Pickups and Transfers (Catalog Numbers 22882, 22876, 22883, & 22068) Uni 20 Uni 45 UniAbutment Replicas (Catalog Numbers & 22070) Version 2.0 August of 37

19 Biomet 3i Flow Chart for Biomet 3i IOL Abutment Impression Copings and Analogs to be used with AccuFrame System IOL Abutments IOL Abutment Pick-Up and Twist Lock Impression Copings (Catalog Numbers IOLPIC and IOLTIC) IOL Laboratory Analog (Catalog Numbers IOLLAS) Version 2.0 August of 37

20 Biomet 3i Flow Chart for Biomet 3i Conical Abutments Impression Copings and Analogs to be used with AccuFrame System Conical Abutments Conical Abutments Pick-Up and Twist Lock Impression Copings (Catalog Numbers MEC33, CSQ17, CSQ06, CSQ07,WCP662, CIC55, CIC56, CIC57,WCT662, and WCT672) Conical Abutment Laboratory Analogs (Catalog Numbers MMCLA, CLA20,WCLA6) Version 2.0 August of 37

21 Biomet 3i Flow Chart for Biomet 3i External Hex implant (3.4, 4.1, and 5.0 only) Impression Copings and Analogs to be used with AccuFrame System External Hex Implant External Hex Implant Pick-Up and Twist Lock Impression Copings (Catalog Numbers MIC33, IIC12, IIC60, IIC75,WIP55,WIP56, and WIP57) External Hex Implant Laboratory Analogs (Catalog Numbers MMILA, ILA20, and ILAW5) Version 2.0 August of 37

22 Hiossen Flow Chart for HIOSSEN HS Octa Abutment System Impression Copings and Analogs to be used with AccuFrame System HS Octa Abutment System Fixture Pick-up Impression Coping (Catalog Number HSFPI48RN, HSFPI48RO, HSFTI4809RN, HSFTI4812RN, HSFTI4809RO, HSFTI4812RO) Fixture Lab Analog (Catalog Number HSFLA48R) Version 2.0 August of 37

23 Keystone Flow Chart for Keystone Indexed Abutments Impression Copings and Analogs to be used with AccuFrame System Indexed Abutments Abutment Pickups and COC Abutment (See special impression technique instructions) (Catalog Numbers S and S ) Implant Analog (Catalog Numbers S2436 and S2505) Version 2.0 August of 37

24 MIS Flow Chart for MIS TransOcta Abutment System Impression Copings and Analogs to be used with AccuFrame System TransOcta Abutment System Fixture Level Impression Components (Catalog Number CD-I0480) Implant Analog (Catalog Number CD-RSM48) Version 2.0 August of 37

25 NEOSS Flow Chart for Neoss Implant Level System Impression Copings and Analogs to be used with AccuFrame System Implant Level System Implant Level Impression Components (Catalog Number 31170, 31145, 31183) Implant Replica (Catalog Number 31170, 31145, Version 2.0 August of 37

26 NEOSS Flow Chart for Neoss Access Abutment System Impression Copings and Analogs to be used with AccuFrame System Access Abutment System Access Impression Components (Catalog Number 31225) Access Replica (Catalog Number 31225) Version 2.0 August of 37

27 Nobel Biocare Flow Chart for Nobel Biocare Multi-Unit Abutments Impression Copings and Analogs to be used with AccuFrame System Multi-Unit Abutments for NobelReplace System and Brånemark Systems Impression Copings Open and Closed Tray (Catalog Numbers 29089, & 29093) Abutment Replica Multi-Unit (Catalog Number 31161) Version 2.0 August of 37

28 Nobel Biocare Flow Chart for Nobel Biocare Brånemark Systems External Hex Implant Impression Copings and Analogs to be used with AccuFrame System Brånemark Systems External Hex Implant Impression Copings Open and Closed Tray (Catalog Numbers 29089, & 29093) Abutment Replica Multi-Unit (Catalog Number 31161) Version 2.0 August of 37

29 Straumann Flow Chart for Straumann SynOcta Abutments for Soft Tissue Implant System Impression Copings and Analogs to be used with AccuFrame System Soft Tissue Implant System SynOcta Abutments Soft Tissue Implant System Fixture Level Impression Components (Catalog Numbers , , , , , & ) Soft Tissue Implant System Analogs (Catalog Numbers & ) Version 2.0 August of 37

30 Straumann Flow Chart for Straumann Multi-Base Abutments for Bone Level Implant System Impression Copings and Analogs to be used with AccuFrame System Multi-Base Abutments Soft Tissue Implant System Fixture Level Impression Components (Catalog Numbers , , , , , & ) Soft Tissue Implant System Analogs (Catalog Numbers & ) Version 2.0 August of 37

31 Sybron Flow Chart for Sybron Octa Abutment System Impression Copings and Analogs to be used with AccuFrame System Octa Abutment System Implant Impression Coping (Catalog Number 5X-142) Implant Analog 4.8 mm Ø (Catalog Number 5X-140) Version 2.0 August of 37

32 Thommen Flow Chart for Thommen SPI VARIOmulti- Abutments Impression Copings and Analogs to be used with AccuFrame System SPI VARIOmulti-Abutments VARIOmulti-Impression Coping (Catalog Number ) VARIOmulti-Analog (Catalog Number ) Version 2.0 August of 37

33 Creation of a Verification Index Cagenix can only guarantee the accuracy of fit according to the stone model the customer sends along with their order form. To ensure the accuracy of the stone cast in relation to the position of the implants and abutments in the patient s mouth, it is recommended that the dentist or laboratory technician create a verification index. The verification index can be created on the stone model utilizing the impression copings/transfers, plastic burnout copings, or temporary abutments for the associated analogs. The impression copings/transfers, burnout copings, and/or temporary abutments will be fixed to the analogs and an acrylic resin material will be used to bridge them together. The bridged impression copings/transfers, burnout copings, and/or temporary abutments will now be placed on the implants and/or abutments in the patient s mouth, where the dentist will assess the fit and alignment of theverification Index. If there is a noticeable misfit/misalignment between the Verification Index and the implants/abutments, a new impression must be made. In an alternative process, the dentist can make an impression and immediately create a verification index in the patient utilizing impression copings/transfers and a cold cure or light cured acrylic resin. This index can be sent with the impression to the lab, where the accuracy of the stone cast can be assessed. If there is a noticeable misfit/misalignment, the stone cast can be modified or a new impression can be made. Version 2.0 August of 37

34 Lab Processing/Framework Veneering Cagenix recommends utilizing the Guide Pins and Processing Screws provided by the implant manufacturer during the acrylic processing and veneering of the AccuFrame. These Guide Pins and Processing Screws provide access holes where the Prosthetic screw can retain the prosthesis to the implants and abutments. Implant Manufacturer Guide Pin/Processing Screw Catalog Number Astra Tech Biomet 3i HIOSSEN Keystone (Stage-1 ) MIS Neoss Nobel Biocare Straumann Sybron Thommen Zimmer Uni Abutment Guide Pin (13 mm) Uni Abutment Guide Pin (16 mm) Uni Abutment Guide Pin (19 mm) Uni Abutment Guide Pin (22 mm) WSK10 Abutment Waxing Screw WSK15 Abutment Waxing Screw WSK30 Abutment Waxing Screw MWS15 Waxing Screw WSU30 Laboratory Waxing Screw HSOPG10 Octa Pickup Guide Pin HSOPG15 Octa Pickup Guide Pin S2403 RDS Indexed Abutment Waxing Pin WDS Waxing Pin CA-GP300 TransOcta Guide Pin N/A (Please contact your local Neoss Rep for more information) Guide Pin Multi-Unit 10 mm Guide Pin Multi-Unit 10 mm (5/pkg) Guide Pin Multi-Unit 20 mm Guide Pin Multi-Unit 20 mm (5/pkg) Guide Pin Implant Level (Brånemark System ) Guide Pin Implant Level (Brånemark System ) Guide Pin Implant Level (Brånemark System ) V4 SCS Guide Screw for RN SynOcta (6.0 mm, cannot be shortened) V4 SCS Guide Screw for RN SynOcta (6.0 mm) V4 SCS Guide Screw for /241 (8.0 mm, cannot be shortened) V4 SCS Guide Screw for /241 (8.0 mm) V4 SCS Guide Screw (10.0 mm) V4 SCS Guide Screw (12.0 mm) V4 SCS Guide Screw (14.0 mm) N/A (Please contact your local Sybron Rep for more information) N/A (Please contact your local Thommen Rep for more information) SCWS Abutment Waxing Screw Version 2.0 August of 37

35 Final Fixation Cagenix recommends utilizing the appropriate Prosthetic Screws provided by the implant manufacturer during the final delivery of the AccuFrame. Implant Manufacturer Prosthetic Screw Catalog Number Astra Tech Biomet 3i HIOSSEN Keystone (Stage-1 ) MIS Neoss Hex Bridge Screw Slot Bridge Screw GSH20 Gold-Tite Retaining Screw GSH30 Gold-Tite Retaining Screw GSH70 Gold-Tite Retaining Screw UNISG Gold-Tite Square Abutment Screw UNIHG Gold-Tite Hex Abutment Screw UNIHT Titanium Hexed Abutment Screw HSOASW EbonyGold Screw for Octa Abutment HSOAST Ti Screw for Octa Abutment S2408 RDS Indexed Abutment Screw WDS Indexed Abutment Screw CA-S0002 TransOcta Abutment Screw Neoss Gold Abutment Screw (Implant Level) Neoss Access Prosthetic Screw Nobel Biocare Prosthetic Screw Multi-Unit (TorqTite ) Abutment Screw TorqTite Abutment Screw TorqTite Abutment Screw TorqTite Straumann Sybron Thommen Zimmer SCS Occlusal Screw Occlusal Screw for Coping on Multi Base Abutment 5X-184 Octa Abutment Retaining Screw Occlusal Screw 3.5 mm SCTS Replacement Screw for Coping Version 2.0 August of 37

36 Description of AccuFrame Bar and Framework Profiles Cagenix offers various bar and framework profiles from which our customers can choose from in the treatment of each individual patient. These profiles can be utilized for removable or fixed prostheses. Fixed Frameworks Y Framework TheY Framework is Cagenix s wraparound framework design. TheY Framework was designed to minimize the size and cross-sectional dimension while providing superior strength. When the dentist or dental laboratory is processing the acrylic for this framework design, they will wrap the acrylic material around the entire framework. The major advantage of this process in comparison to a metal base framework is acrylic material can be added or removed if the patient s soft tissue contours change over time. This framework design is also useful when there is a limited amount of height. Arms Cagenix does allow for slight modifications of the length and angulations of the arms of they Framework. Version 2.0 August of 37

37 Metal Base Framework The Metal Base Framework provides a fixed framework design with a metal base finish on the bottom of the prosthesis. The metal base provides a finishing line where the acrylic can be processed to and finished by the dentist or dental laboratory. The straight bar portion provides a support structure for the acrylic teeth as well as providing holes to ensure the acrylic material is well retained to the framework. Support Bar Finish Line Base The height of the Support Bar portion of the framework can be extended taller and the width and the height of the Metal Base can be extended as well. Version 2.0 August of 37

38 Removable Bars Hader Bar The traditional Hader Bar is used for a removable prosthesis. The Cagenix Hader Bar is compatible with all Hader clips currently sold in the market. The rectangular portion of the Hader Bar can be shortened or lengthened to provide additional support and strength. Dolder Bar The Dolder Bar is also a classic bar design used for removable cases. The Dolder Bar design is also compatible with all Dolder clips currently sold on the market. No modifications are available to the Dolder Bar. Version 2.0 August of 37

39 Locator Bar The Locator Bar is another classic design for a removable prosthesis, which provides threaded holes for the attachment of one or more Locator Abutments. The Locator Bar design is compatible with the Zest Locator Bar Abutments (2 mm) currently sold on the market. The customer needs to mark on the stone cast the proposed location of the Locator Abutments. Slight height modifications are available for the Locator Bar. Version 2.0 August of 37

40 Notices Warning The descriptions given are insufficient to enable a dentist or technician to immediately use the Cagenix AccuFrame. Guidance in the handling of the AccuFrame by an operator experienced in its use is strongly recommended. The AccuFrame must only be used by dental laboratory technicians, dentists, doctors, and operators who have completed appropriate training. Disclaimer of Liability The user of Cagenix products must rely on their professional training, expertise and judgment to determine whether any product is suitable for the particular patient and each individual s clinical circumstances. Cagenix disclaims any liability for any direct, indirect, punitive or other damages, arising out of or in connection with any errors in professional judgment or practice in the use or installation of Cagenix products. In cases of doubt, the user has to contact Cagenix for assistance regarding the use of our products. We have no control over the chosen utilization of this product in the hands of the dental laboratory technician, dentist, doctor, or operator. We assume no liability whatsoever for damage arising from this chosen utilization. Cagenix can only guarantee a fit to the stone cast sent by the dental laboratory technician, dentist, doctor, or operator. It is the customer s responsibility to ensure an accurate impression and stone cast have been created and the appropriately listed impression transfer copings and analogs have been used. The list of impression transfer copings and analogs can be found in the Cagenix AccuFrame Procedure and Laboratory Manual. It is important to ensure that as many implants are available as necessary for the creation of a stable framework. The Procedure and Laboratory Manual for the Cagenix AccuFrame System lists Design Parameters which should be abided in the design and fabrication of any AccuFrame. It shall be the responsibility of the customer to accept the liability for any direct, indirect, punitive or other damages that may arise from the utilization of any AccuFrame that exceeds these design parameters as designed and fabricated per the customer s request, direction, and approval. Supply and availability Products are currently limited to the United States of America. Copyright and Trademarks Cagenix documents may not be reprinted or published, in whole or part, without the written authorization of Cagenix. Explanation of Labeling ORD is the unique part identification number given to the AccuFrame by Cagenix. All information regarding the AccuFrame can be located through this number. LOT is a number which references the lot of material from which this AccuFrame was milled from. MAT is the material or alloy from which the AccuFrame was milled from. Customer is the name of the customer who ordered the AccuFrame being delivered. CSN may be a Purchase Order Number or unique identifying number disclosed by the dental laboratory. NonSterile, this product is not sterile. Before the AccuFrame is placed in the patient s mouth, the framework needs to be disinfected by the dentist. Rx Only denotes that this product is for prescription use only. If there are any questions regarding the labeling, please contact customer service at Sterilization This product is provided to the customer nonsterile. Cagenix recommends that the dentist disinfects the AccuFrame prior to placement by a means deemed acceptable in common practice. Cagenix cannot be held liable for any damages that may arise, if the dentist does not disinfect the AccuFrame appropriately. Delivery of AccuFrame to Patient s Mouth For screw retained connections, follow the implant manufacturer s recommended directions for the delivery of a prosthesis. Warranty The Cagenix AccuFrame has a warranty for 15 years. This warranty only covers breakage through normal use. Failure due to accidents or improper use by our customers will not be covered. If the customer alters the framework in any way, this warranty will no longer be valid.this warranty will only cover AccuFrames which abide to the Cagenix AccuFrame Design Parameters as defined in the Procedure and Laboratory Manual for the Cagenix AccuFrame System. Any AccuFrame that exceeds these Design Parameters will be considered custom and no warranty will be provided for this particular AccuFrame. Returns If there is a question regarding the fit, the customer may contact Cagenix ( ) and request a return. Returning the AccuFrame does not guarantee a reimbursement or a remake of the order. The returned AccuFrame will be reviewed by our engineering staff and the appropriate action will be determined. Version 2.0 August of 37

41 Contact Cagenix, Inc. 795 Ridge Lake Blvd. Suite 107 Memphis,TN cagenix.com Cagenix, Inc. AccuFrame is a registered trademark of Cagenix, Inc. All rights reserved. All trademarks acknowledged. 28 of 28