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Missing tooth structure in anterior and posterior teeth Types of restorations: - Veneers - Inlays - Onlays (e.g. occlusal veneers, partial crowns) - Crowns

IPS e.max® One is a glass-ceramic block for the fabrication of fixed, full-contour single-tooth restorations in anterior and posterior teeth. IPS e.max One can be processed in milling machines and polished afterwards. A crystallization process is not necessary. The dentist starts with shade selection, preparation of the tooth based on guidelines for all-ceramic restorations, follow the recommended griding instruments and minimum layer thickness during finalizing and finishing, and finish with dental polishing. Types of restorations: -Veneers -Inlays -Onlays (e.g. occlusal veneers, partial crowns) -Crowns

Tetric® CAD is intended for: - Veneers - Inalys - Onlays (e.g. occlusal veneers, partial crowns) - Crowns in the anterior and posterior region

Tetric® CAD is a composite block for the fabrication of esthetic permanent inlays, onlays, veneers and crowns in the anterior and posterior region. Fabrication of the dental restoration is performed at the dentist's office in a compatible milling machine. The blocks are composed of cross-linked dimethacrylate and inorganic fillers. In the processing technique, the restoration is polished and seated after milling in the CAD/CAM system. The blocks are attached to a metal mandrel, the geometry of such is compatible with a milling machine, e.g. Cerec/InLab (Sirona), PlanMill (PlanMeca) or Programill One (Ivoclar Vivadent). Tetric® CAD composite blocks are available in the translucency levels MT (5 shades - A1, A2, A3, A3.5, BL) and HT (4 shades 0 A1, A2, A3, A3.5), and in the sizes I12 and C14.

IPS e.max® Press Abutment Solutions for Viteo Base Ti is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multi-unit cement retained restorations. IPS e.max Press Abutment Solutions is recommended for the fabrication of: - Hybrid abutments for single-tooth restorations - Hybrid abutment crowns for restorations

IPS e.max Press Abutment Solutions for Viteo Base Ti is a prefabricated prosthetic component for endosseous dental implants to support prosthetic restorations in partially or fully edentulous jaws. The Viteo Base-Ti is the apical component of a two-piece abutment. A separate mesostructure fabricated out of IPS e.max Press ceramic is attached to the Viteo Base-Ti extraorally using Multilink Hybrid Abutment Cement (K130436). This part then serves as an intermediary to facilitate the connection of the 2-part abutment to the prosthetic material (crown). The abutment as a whole is intended to be used as an aid in prosthetic rehabilitation for the purpose of providing a suitable chewing function. A compatible screw is included with the Viteo Base-Ti for attachment of the completed hybrid abutment to the implant body. Alternatively, the mesostructure may be fabricated into the prosthetic restoration and attached to the Viteo Base-Ti via the screw to form a hybrid crown/abutment, thereby incorporating the top half of the two-piece abutment into the body of the crown. The Viteo Base Ti is made of Ti-6Al-4V ELI Titanium Grade 23 and is provided with a compatible screw made of the same materials. Viteo Base-Ti is available in two platform sizes (SD and MD) for various cleared implant systems as described in this summary. The upper part (pillar) of the Viteo Base Ti can be shortened individually, has a blasted surface to support bonding of the restorative part, and has an internal retentive lock to circumvent rotation. The IPS e.max Press Abutment Solutions for Viteo Base Ti are parts of the implant system which consists of: - Implant Body – marketed by the Implant Manufacturer - Viteo Base Ti - Titanium part Included in subject device - Screw - Titanium screw Included in subject device - IPS e.max Press either as a part of the abutment or a Hybrid Abutment crown included in the subject device. - Multilink Hybrid Abutment Cement – to bond together the Viteo Base Ti abutment part and the IPS e.max Press ceramic part included in the subject device.

Intended Use: IPS Style Press - Pressing on metal frameworks and superstructures for the fabrication of full-contour crowns and bridges (staining technique) - Pressing on metal frameworks and superstructures for the fabrication of partially anatomic crowns and bridges (cut-back technique) - Pressing of ceramic margins (metal-ceramic) - Pressing of gingiva components (metal-ceramic) - Processing on the most popular dental alloys in the CTE range of 13.8 14.5 10-6/K - (25 500°C) (Cu< 1%, Ag < 10%) - -- Veneering with the layering materials of IPS Style in the conventional layering technique - Characterization with IPS Ivocolor Shade and Essence stains - Glazing with IPS Ivocolor Glaze Intended Use: IPS Style Ceram and IPS Style Ceram Onc - Conventional multi-layer veneering ceramic for the most popular dental alloys (including electroplating) in the CTE range of 13.8 - 15.2 x 10-6/K (25 - 500°C) (IPS Style Ceram) - One-layer veneering ceramic for the most popular dental alloys (including electroplating) in the CTE range of 13.8 - 15.2 x 10-6/K (25 - 500°C) (IPS Style Ceram One) - Veneers on refractory die material (only IPS Style Ceram) - Characterization and veneering of IPS Style Press restorations - Characterization with IPS Ivocolor Shade and Essence stains - Glazing with IPS Ivocolor Glaze

IPS Style comprises both materials for the conventional veneering technique and the press technique. - . IPS Style Ceram: is available as Opaquer 870 in 42 Shades, Opaquer 960 in 42 shades, Margin Powder in 11 Shades, Dentin porcelain in 32 Shades, deep Dentin porcelain in 16 Shades, Incisal Porcelain in 10 Shades, Transparent Porcelain 7 Shades, Mamelon in 3 shades, Occlusal Dentin 2 Shades, Incisal Edge 1 Shade, Opal Effect in 6 Shades, Special Incisal 2 Shades, Inter Incisal 1 Shades, Cerv. Transparent 4 Shades, Add on Ceramic 4 Shades, Bleach Ceramic in 14 Shades, Gingiva Porcelain in 11 Shades and 4 Liquids. - IPS Style Ceram One: is available in 16 Shades and Shades Guides . - . IPS Style Press: Press Ingots LT is available in 8 Shades, Press Ingot HT in 8 Shades and Press Ingot Gingiva in 1 Shade. - . IPS Style Liquids including Build-up and Opaquer which burn out after firing.

Staining and/or characterization and glazing of ceramic materials from Ivoclar Vivadent and Wieland Dental: - Veneering ceramics - Press ceramics - Milling ceramics - Zirconium oxide (framework and full-contour)

IPS Ivocolor is a universal stains and glaze assortment consisting of 23 shades of Essence porcelain, 9 shades of Dentin porcelain, 3 incisal porcelains, 2 Glaze powders, 2 glaze pasts, 2 Mixing Liquids, Essence fluid and shade guides. The range of products has been coordinated with the layering, press and CAD Ceramics from Ivoclar Vivadent and the zirconium oxides from Wieland Dental and be used regardless of the CTE of the ceramic. The difference is that IPS Ivocolor can be used with both metal-ceramic and fullceramic materials.

Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months). The system comprises three parts: - Telio CAD Abutment Solution - Ti base and - CAD/CAM software Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants.

Telio CAD Abutment Solutions are resin blocks with an interface hole in Small and large sizes to accommodate Sirona Ti bases (K100152 and K111421) in the fabrication of temporary hybrid abutment crowns. The Device is milled using CAD/CAM Technology then cemented to the Sirona Ti base and used for the purpose of temporary hybrid abutment crowns in coniunction with endosseous dental implants. Hybrid abutment crowns are characterized by combining a Ti base and monolithic crown in one piece. Telio® CAD Abutment Solutions are CAD/CAM-fabricated implant-supported hybrid restorations for individual, temporary single-tooth reconstructions. The material consists of a cross-linked polymer block (PMMA), enabling the fabrication of individual, monolithic hybrid abutment crowns which are directly cemented to a Ti base. Shape, esthetics and emergence profile can be easily designed and adjusted any time.

– As initial layer / first increment in Class I and II composite restorations in permanent teeth - Restorations in deciduous teeth

Tetric EvoFlow® Bulk Fill is a flowable, light-curing radiopaque composite. As its opacity increases during polymerization, it is also suitable for discolored tooth structure. It is applied in increments of up to 4 mm as an initial layer in Class I and II restorations. Tetric EvoFlow Bulk Fill is intended for use as a dental filling material.

Conditioning of silica-based ceramic surfaces for the adhesive bond with luting composites

Monobond Etch & Prime is used to condition silica-based ceramic surfaces for the adhesive bond with luting composites from the Variolink or Multilink product lines, for example, Monobond Etch & Prime etches and silanizes silicate ceramic suffaces in one working step. The new product combines the role of bonding agent with that of etchant. Typically the dental technician would etch the ceramic with 5% hydrofluoric acid but this step is achieved using Monobond Etch & Prime. The etching step was carried out outside the mouth and the new product is also limited to extra-oral applications of the new product are limited to silica ceramics, Oxide ceramics, metal, composite and fibre-reinforced composites are not indicated. This is because only silica glass ceramics required etching with hydrofluoric acid and therefore the benefit of using Monobond Etch & Prime is primarily relevant for this group of materials.

Variolink Esthetic LC: – Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers) - Only use Variolink Esthetic LC for restorations with a low thickness of <2mm that have sufficient translucency (e.g. restorations made of IPS e.max R HT). Variolink Esthetic DC: - Adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays, partial crowns, crowns, bridges). - Restorations made of opaque ceramics, e.q. oxide ceramics, can only be permanently cemented if an adhesive is additionally used that is separately light-cured. Variolink Esthetic Trv-In To evaluate the overall effect of the restoration in conjunction with the various Variolink Esthetic shades prior to permanent cementation.

Variolink® Esthetic is a color-stable adhesive luting system for the permanent cementation of ceramic and composite resin restorations. Variolin Esthet6ic is offered in a purely light-curing (LC) and dual-curing (DC) version. Try-In pastes are also included for shade matching purposes. The materials are offered in five shade gradations (Light+, Light, Neutral, Warm and Warm+)

- Treatment of dentinal hypersensitivity - Treatment of exposed cervicals - Treatment of sensitivity after tooth whitening

Fluor Protector S is a desensitizing agent used for sealing of dentinal tubules for the treatment of hypersensitive teeth, sensitive root surfaces and for cavity preparation. The primary difference between the subject device and the predicate device is the use of Ammonium fluoride in the subject device. Even though there is an approximately 8-fold difference in fluoride content in solution between the subject device and the predicate device, the difference is only 3.6-fold in the dry varnish, which is the "active state" of the device. Apart from fluoride content, the varnishes are very similar (low viscosity, clear, transparent, multi- and single dose).