Warnings: Precautions:

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1 CAD/CAM and Instructions for Use Cercon base, Cercon base light, Cercon base medium, Cercon base colored (short: Cercon base) and Cercon ht, Cercon ht light, Cercon ht medium Cercon base PMMA, Cercon base cast, Cercon wax for Cercon brain and Cercon brain expert

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3 Cercon base, Cercon base light, Cercon base medium, Cercon base colored, (short: Cercon base), Cercon ht, Cercon ht light, Cercon ht medium (short Cercon ht) : Cercon base / Cercon ht blanks are made of yttria-stabilized zirconia (Y-TZP). They are used in fabricating frameworks for fixed prosthetic restorations using Cercon brain / Cercon brain expert. They are made of an oxide ceramic material characterized by particularly high-strength. These blanks are available in white (Cercon base) and three gradations of ivory (Cercon base light, Cercon base medium, Cercon base colored). A highly translucent variant (Cercon ht, Cercon ht light and Cercon ht medium) offering particularly pro-nounced light transmission completes this product range. Depending on the framework design, Cercon base / Cercon ht frameworks can be ceramically veneered or inserted as fully anatomic restorations. Which blank is selected will depend on the shade to be reproduced and the space available for the veneer. With fully anatomic restorations, no space is required for the ceramic veneer, which may allow the dentist to preserve more of the tooth substance during preparation. Framework material Temporary cementation Definitive cementation Using Cercon brain / Cercon brain expert, your restorations and frameworks are individually fabricated to your digital design specifications such as anatomic shape, framework wall thickness and connector diameter or cementing gap. Always use the most current version of the design software, as this may influence the production of your restorations. As per May 2011, the most current software version for Cercon art is version Zirconia Y-TZP Possible Adhesive luting Conventional cementing Indications in the anterior and posterior segments: Cercon base / Cercon ht is indicated for Crowns Telescopic primary crowns Multi-unit bridges (with no more than two pontics between abutment crowns) Abutments Cercon base / Cercon ht can be used as a substructure (framework) which is then veneered with a dental veneering ceramic or can be used for full-contour application (without veneering) as well. In the case of Telescopic primary crowns and abutments the substructure is not veneered. Contraindications: In patient hypersensitivity to zirconia or one of the other ingredients, this medical product may not be used at all or only under the particular scrutiny of the dentist or physician in charge Bruxism or recalcitrant parafunctional habits (as usual for all ceramically veneered frameworks) Insufficient available space Inlay bridges Endodontic posts Endosseous implants Warnings: Known cross-reactions or interactions of this medical product with other medical products or material already present in the oral environment must be taken into consideration by the dentist in charge when selecting this medical product. Precautions: Please note: Keep product dust away from eyes Avoid any contact with mucosa After use, wash your hands and apply a hand cream When using, do not eat or drink, do not ingest, do not inhale dust particles Use local suction and suitable mouth/ face protection during grinding Processing the material will result in the release of dust that may cause irritation of the eyes, skin or respiratory passages. The overall maximum workplace concentration (MAK) for zirconia under German occupational health regulations is 1 mg/m³, which means that local suction must be ensured during all processing. The safety and warning notes listed here describe how to use our system components in a safe and risk-free manner. Notify the dentist in charge of all factors described above if you use this medical product for a custom design and make sure to comply with the Instructions for Use and the pertinent Material Safety Data Sheets (MSDS). 3

4 Adverse effects: We are not aware of any risks or adverse effects related to Cercon base / Cercon ht. If properly processed and used, adverse effects of this medical product are highly unlikely. However, reactions of the immune system (such as allergies) or In doing so, however, make sure that the relief of the occlusal surfaces is not modified by deepening existing fissures, as this might compromise the stability of the material due to notching action. Note that a shallow occlusal relief will increase the life expectancy of fully anatomic restorations. localized paraesthesia (such as an irritating taste or irritation of the oral mucosa) cannot be completely ruled out as a matter of principle. Should you learn of any adverse effects even questionable ones you are requested to notify us. Framework dimensions (anterior and posterior): When manually finishing the frameworks, never (!) segment them interdentally with cutting wheels or other rotary instruments, because this, too, might result in notching and reduced stability. Wall thickness-single crowns Margin thickness-single crowns Wall thickness-bridges Margin thickness-bridges Additional dimensional requirements for the anterior region: 0,4 mm 0,2 mm 0,5 mm 0,2 mm Important note: Always make sure that the minimum thickness of the framework in the occlusal area meets the minimum-thickness requirements even after subsequent occlusal adjustment. Framework design for ceramic veneering Number of pontics 2 Connector cross section 6 mm 2 Frameworks to be ceramically veneered must be designed to a reduced anatomical shape for the veneer to receive maximum support by the framework. Additional dimensional requirements for the posterior region: Number of pontics 2 The frameworks can be veneered using either the pressing technique or the buildup technique. Connector cross section 9 mm 2 Cantilever pontic at tooth position (only one pontic, up to one premolar width) Connector cross section for this cantilever pontic Up to second premolar 12 mm 2 Technical specifications: Typ II, Class 6 (according to DIN EN ISO 6872; 2009) CTE: 10.5 ( C) Modulus of elasticity: 210 GPa General notes on framework design: Fully contoured framework design Indicated especially where little occlusal space is available, where Composition (in mass %): Zirconia Yttria 5% Hafnium oxide <2% resp. <3% (Cercon ht) Alumina and silica < 1% (Total 100%) the restoration will be inserted without prior veneering or where the restoration will be individually characterized using body stains. Fully contoured framework designs will be given the most suitable surface shape and texture automatically, as the Cercon brain / Cercon brain expert milling strategy uses a particularly fine cutter. The framework surface thus attained can be additionally polished carefully (!) before sintering, using rotary instruments such as fine cutters or wheels. Finishing: Processing with Cercon brain: Processed in the same manner as all Cercon base / Cercon ht shades. For detailed instructions, please refer to the Cercon brain Instructions for Use. Processing with Cercon brain expert: For processing the blanks, use Type 0 Cercon brain expert cutters (ZrO 2 ). For detailed instructions, please refer to the Cercon brain expert Instructions for Use. 4

5 Sintering with the Cercon heat plus Cercon base, Cercon base light, Cercon base medium, Cercon base colored: Frameworks made of these materials are sintered at C in the Cercon heat furnace or at C bzw C in the Cercon heat plus furnace - Program #1 for bridges of up to eight units, T max. =1.350 C - Program #2 for bridges of up to eight units, T max. = C - Program #3 for bridges of nine units or more T max. = C** Cercon ht, Cercon ht light, Cercon ht medium: Frameworks made of Cercon ht are sintered at C in the Cercon heat plus furnace - Program #4 for bridges of up to eight units, T max. = C - Program #5 for bridges of nine units or more, T max. = C Sintering tray with sintering block. Correct position on the sintering tray. Sandblasting: The sandblasting aid facilitates the removal of the object from the blank. It helps prevent framework fracture or other damage to the workpieces. Use alumina (50 µm, max. 1.5 bar) to sandblast on the labial and buccal sprues of the object and the tongue connector, because the object must be sintered together with that tongue. By trimming excess edges at the bottom of the tongue you can give the object more stability on the sintering block. (The smaller objects nested inside the tongue are detached completely and sintered separately.) Special sintering notes applicable to large-span bridges (> 9-gliedrig) in Cercon heat plus: Nesting: To ensure homogeneous contraction, nest smaller objects (such as single copings or three-unit bridges) on the inside ( tongue ) of larger workpieces. Sandblasting aid. Sandblasting the workpieces. Separation: The object is separated from the tongue using diamond cutters under irrigation. Before milling: Completely remove the barcode label from the blank to avoid contamination of the sintering furnace (Cercon heat plus). Manual finishing after sintering: Sandblast the inside and outside of the framework with alumina ( µm, max. 3 4 bar, 45 angle). Sintering: Only two wide-span bridges (> 8 units) can be sintered in the Cercon heat plus at a time. Place the object on the sintering block, with due regard to the internal vertical clearance of the Cercon heat plus (130 mm) and the need to facilitate contraction without any mechanical constraints. The bridge must not touch the sintering block during the sintering. Eliminate premature contacts one by one until the framework has reached its final position on the die(s). During the try-on and fitting of the framework, keep the dies on the cast and try on the framework as a whole. Once the try-on and fitting work has been completed, do not perform any additional adjustments such as finishing the entire framework. 5

6 Note: Zirconia crown or bridge abutments should fit passively, without friction. The rationale for requiring a passive fit lies in the physical properties of the material itself: Ceramics will tolerate compressive stress but not tensile stress. In crowns that exhibit a friction fit, this friction is generated by certain bearing parts of the framework, as the crown itself never rests completely on the die due to processing-related surface roughness (the same actually holds for cast-metal frameworks). It is only the peaks of the surface roughness (the named bearing parts) that are in contact with the die surface. This converts the compressive forces generated by masticatory pressure into tensile forces, which may well damage the crown. Adapt the framework margins exactly to the preparation margins. Note: Zirconia should be finished using diamond instruments under proper irrigation only. Keep the pressure on the framework material to a minimum and work only in one direction. Sandblast the finished areas once again with alumina ( µm, max. 3 4 bar, 45 angle). Finally, clean the framework using a steam cleaner. Veneering / shading: You may need to adapt your usual build-up procedure to the respective Cercon base shade. Please read instructions for use of the used veneering ceramic. Note that Cercon ht exhibits high levels of light transmission due to its pronounced translucency. General Notably, reproduction of the custom shade is potentially influenced by: Die shade Colour of the material used for temporary/definitive cementing Wall thickness of the framework Use of liner Build-up technique It is recommended to use Cercon ceram kiss / Cercon ceram press / Cercon ceram love (ceramic veneering materials) for veneering zirconia frameworks. Make sure to follow the applicable Instructions for Use. Annealing: Based on the results of our scientific testing of zirconia frameworks, we consider a separate annealing ( healing ) step both unnecessary and inappropriate. In-laboratory polishing: Unveneered zirconia frameworks should not be inserted without polishing them to a high luster or sealing them with a glaze in order to protect the antagonists from abrasion. In addition, polishing or glazing the restoration supports patients in their efforts at oral hygiene. In-office polishing: Comprehensive DeguDent-initiated studies have demonstrated the abrasive effect of Cercon base / Cercon ht on the antagonist not to exceed that of commercially available ceramic veneers or lithium disilicate ceramics not even after adjusting on polishing. Strictly for prevention purposes we recommend, following final intraoral occlusal adjustment of the restoration, polishing any adjusted surfaces to a high lustre or sealing them with glaze before temporary or definitive cementing. This is very important as it protects the antagonists from possible abrasion. In addition, polishing or glazing the restoration supports patients in their efforts at oral hygiene. Shades finalized by staining may result in bright spots where the stain was removed during occlusal adjustment. Transport and storage: There are no special terms. Staining technique For tooth-coloured staining of fully anatomic Cercon base / Cercon ht restorations, we recommend our Cercon ceram body stains. 6

7 Cercon base PMMA : Cercon base PMMA are made of polymethylmethacrylate. They are used in fabricating provisionals for crown and bridge frameworks for fixed prosthetic restorations. Framework material Polymethylmethacrylat Indications in the anterior and posterior segments: Crowns Multi-unit bridges (with one pontic between abutment crowns) Cantilevered-pontic bridges are fabricated at the ordering laboratory s risk. All provisionals should not be worn for longer than six months. Temporary cementation Yes Definitive cementation Contraindications: Using Cercon brain/cercon brain expert, your restorations and frameworks are individually fabricated to your digital design specifications such as anatomic shape, framework wall thickness and connector diameter or cementing gap. Always use the most current version of the design software, as this may influence the production of your restorations. As per May 2011, the most current software version for Cercon art is version In patient hypersensitivity to polymethyl methacrylate or one of the other ingredients, this medicinal product may not be used at all. Warnings: Known cross-reactions or interactions of this medical product with other medical products or material already present in the oral environment must be taken into consideration by the dentist in charge when selecting this medical product. Processing Cercon base PMMA disk will result in the release of dust that may cause irritation of the eyes, skin or respiratory passages. The legal threshold limit value (TLV) for methylmethacrylate in Germany is 210 mg/m³. To ensure safe and sustainable compliance, the measured value must not exceed 25% of the TLV. This in turn requires that the room in which the Cercon brain expert is used to process this material (max. 2 disks per 8 hours) must have a volume of at least 28 m³. In rooms with a smaller volume, the air exchange rate must be increased by a suitable HVAC installation. Precautions: Please note: Keep product dust away from eyes Avoid any contact with mucosa After use, wash your hands and apply a hand cream When using, do not eat or drink Do not swallow Do not inhale dust particles during grinding Use local suction and suitable mouth/face protection during grinding. Wear protective gloves when replacing or disposing of dust filter bags. 7

8 The safety and warning notes listed here describe how to use our system components in a safe and risk-free manner. Notify the dentist in charge of all factors described above if you use this medical product for a custom design and make sure to comply with the Instructions for Use and the pertinent Material Safety Data Sheets (MSDS). Adverse effects: We are not aware of any risks or adverse effects related to Cercon base PMMA. If properly processed and used, adverse effects of this medical product are highly unlikely. However, Technical specifications: Density: 1.19 g/cm³ Solubility: 7.5 µg/mm³ Flexural strength: 65 MPa Water sorption: 40 µg/mm³ Flexural modulus: 2,000 MPa Composition (in mass-%): Polymethyl methacrylate and cross-linked copolymers of methacrylic acid > 99% Pigments (predominantly iron oxide pigments and benzoyl peroxide) < 1% Polymethyl methacrylate may contain up to approx. 1% residual monomer (Total 100%) reactions of the immune system (such as allergies) or localized paraesthesia (such as an irritating taste or irritation of the oral mucosa) cannot be completely ruled out as a matter of principle. Should you learn of any adverse effects even questionable ones you are requested to notify us. Framework dimensions (anterior and posterior): Manual finishing: To remove a framework from the blank and to finish the framework, cross-cut tungsten-carbide cutters suitable for cutting resin or appropriate separating disks must be used. To avoid an imprecise fit of the completed framework, subsequent to framework avoid excessive heat during finishing and polishing. Wall thickness, single crowns Margin thickness-single crowns Wall thickness-bridges Margin thickness-bridges 1,0 mm 0,2 mm 1,0 mm 0,2 mm Veneering: Not applicable. Additional dimensional requirements for the anterior region: Transport and storage: Store dry. Number of pontics 1 Connector cross section 9 mm 2 Additional dimensional requirements for the posterior region: Number of pontics 1 Connector cross section 9 mm 2 Reuse: As each restoration or frameworks is a custom product for a specific patient and case, the product is not reusable in any dental rehabilitation setting other than that for which it has been prescribed. In addition, the framework cannot be reused for refabrication or any other subsequent therapeutic purpose. Cantilever pontic at tooth position (only one pontic, up to one premolar width) Connector cross section for this cantilever pontic Kontraindiziert 8

9 Cercon base cast, Cercon wax Cercon base cast: Cercon base cast blanks are made of polyurethane, which is a casting resin that leaves no residue. They are used in fabricating frameworks for the conventional casting technique. Indications in the anterior and posterior segments: Depending on the properties of the CAD/CAM system and the casting alloy used. Framework material Polyurethan Contraindications: Temporary cementation Definitive cementation No Cercon base cast and Cercon wax have not been approved for intraoral use. Cercon wax: Cercon wax blanks are blanks made of a milling wax that leaves no residue after firing. Shey are used in fabricating frameworks for the casting technique. Framework material Wax Temporary cementation No Definitive cementation Using Cercon brain/cercon brain expert, your restorations and frameworks are individually fabricated to your digital design specifications such as anatomic shape, framework wall thickness and connector diameter or cementing gap. Always use the most current version of the design software, as this may influence the production of your restorations. As per May 2011, the most current software version for Cercon art is version Warnings: Known cross-reactions or interactions of this medical product with other medical products or material already present in the oral environment must be taken into consideration by the dentist in charge when selecting this medical product. Processing Cercon base cast / Cercon base cast disk / Cercon wax will result in the release of dust and chips that may cause irritation of the eyes, skin or respiratory passages. Provide a sufficient local workspace vacuum throughout. For safety requirements while burning out the material, please consult the pertinent information in the Cercon base cast Instructions for Use. When burning out Cercon wax from the casting mould, observe the same safety precautions as for conventional wax casting molds (removing wax fumes by vacuum). Precautions: Please note: Keep product dust away from eyes Avoid any contact with mucosa After use, wash your hands and apply a hand cream When using, do not eat or drink Do not swallow Do not inhale dust particles during grinding Use local suction and suitable mouth/face protection during grinding The safety and warning notes listed here describe how to use our system components in a safe and risk-free manner. Notify the dentist in charge of all factors described above if you use this medical product for a custom design and make sure to comply with the Instructions for Use and the pertinent Material Safety Data Sheets (MSDS). 9

10 Adverse effects: We are not aware of any risks or adverse effects related to Cercon base cast / Cercon wax. If properly processed and used, adverse effects of this product are highly unlikely. Should you learn of any adverse effects even questionable ones you are requested to notify us. Framework dimensions (anterior and posterior): Wall thickness, single crowns Margin thickness, single crowns Wall thickness, bridges Margin thickness, bridges Additional dimensional requirements for the anterior region: 0.4 mm or as directed by the 0.2 mm or as directed by the 0.5 mm or as directed by the 0.2 mm or as directed by the Number of pontics 2 Connector cross section Additional dimensional requirements for the posterior region: 9 mm 2 or as directed by the Number of pontics 2 12 mm 2 or as directed by the Connector cross section Cantilever pontic at tooth Up to position (only one pontic, up to second premolar one premolar width) Connector cross section for this cantilever pontic 16 mm 2 or as directed by the Technical specifications: Composition Cercon base cast: Polyurethan Composition Cercon wax: Microwax Resins Paraffins Pigments Polyethylene wax LD polyetylene homopol Esters of hydrated colophon Additives. Processing with Cercon brain expert: For processing Cercon base cast disk or Cercon wax disk, use Type 2 Cercon brain expert cutters (PMMA). For detailed instructions, please refer to the Cercon brain expert Instructions for Use. Manual processing: Cercon wax can be processed using a high-speed procedure, as the material can be burned-out without increasing in volume. To remove a framework from the blank and to finish the framework, cross-cut tungsten-carbide cutters suitable for cutting resin or appropriate separating disks must be used. To avoid an imprecise fit of the completed framework, subsequent to framework avoid excessive heat during finishing and polishing. Veneer Cercon base cast / Cercon wax: Not applicable. Transport and storage: No special terms. Reuse: As each restoration or frameworks is a custom product for a specific patient and case, the product is not reusable in any dental rehabilitation setting other than that for which it has been prescribed. In addition, the framework cannot be reused for refabrication or any other subsequent therapeutic purpose. 10

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12 Fascination Prosthetics GB 28239/1112/DB Last revision: 12/2011 DeguDent GmbH Rodenbacher Chaussee Hanau-Wolfgang Germany