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- Missing tooth structure - Defective restorations

Adhese Universal DC is a dual-curing, single-component dental adhesive for enamel and dentin that is compatible with all etching techniques (self-etch, selective enamel etch, etch & rinse techniques). The areas of application include adhesive cementation of indirect restorations and direct restorative procedures. Adhese Universal DC is available in Free Stand Single Dose units. The applicator is coated with co-initiators required for the self-curing reaction. The initiator and adhesive are mixed together by dipping the applicator into the single dose unit containing the liquid Adhese Universal DC.

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 Solutions - Ti base and (Dentsply Sirona K181520, Camlog K083496, Conelog K143337, iSy K133991) - CAD/CAM software: Sirona Dental CAD/CAM System (K100152, K111521, K181520) Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants. The compatible implant systems, CAD/CAM systems and Ti bases are shown below: -Implant systems: The Telio CAD PMMA structure and TiBase hybrid abutment is compatible with the following implant systems: - AstraTech Osseospeed (Dentsply Sirona K130999, K091239) - Frialit/Xive (Dentsply Sirona K013867)) - internal connection (BioHorizons K143022, K071638, K093321, K042429) - Replace (Nobel Biocare K020646) - Nobel Active (Nobel Biocare K071370) - Bränemark® (Nobel Biocare K022562) - Tissue Level (Straumann K061176) - Tapered Screw-Vent (Zimmer K061410) - Camlog Screw-Line (Camlog K083496) - Conelog Screw-Line (Camlog K113779) - iSy (Camlog K133991) - Osstem TS (Osstem (USA: Hiossen) K121585)

The Telio® CAD Abutment Solutions- extra systems which is the subject of this premarket notification is a modification to the Telio Abutment Solutions as previously cleared under K151564. The modifications represented in the subject device consist of the addition of 14 extra implant systems to the 2 previously cleared implant systems. The device Telio CAD (K093708) is currently cleared by the FDA as a Crown and Bridge, Temporary Resin (21 C.F.R§872.3770) because it is a device that offers a rapid route to effective temporary restorations. The currently cleared Telio CAD Abutment Solutions (K151564) included the system Straumann Bone Level, but not all the parts of this system (i.e. NC) were mentioned. This submission includes 14 additional systems. Telio CAD Abutment Solutions- extra systems is intended for use in single hybrid abutment crowns for temporary restoration (up to 12 months). Telio CAD Abutment Solutions is a system comprising of three parts: Telio CAD Abutment Solution, cross-linked polymer block (PMMA), enabling the fabrication of individual, monolithic hybrid abutment crowns which are directly cemented to a Ti base, utilizing Sirona CAD/CAM System to design and fabricate long term temporaries by means of the CAD/CAM technique. The abutments being two-piece titanium base abutments are mated with a PMMA top-half, in which the assembly comprises the final-finished medical device of a patient-specific dental abutment. For the fabrication of Telio CAD Abutment Solutions, the clinical situation is digitalized either by a direct intraoral scan or an indirect model scan, depending on the CAD/CAM system used. For notes regarding the scan, please observe the manufacturer's instructions for use of the CAD/CAM system.

For treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces.

Cervitec®F is a dental varnish for the treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces. The varnish system is characterized by its good moisture tolerance during application. Cervited in either a Tube (4gm, 7gm) or Single Dose (0.26gm) delivery form.

Barrier Sleeves are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

Barrier Sleeves are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment of the devices used during dental procedures. Barrier Sleeves act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.

IPS e.max® CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The system comprises three parts: - IPS e.max CAD ceramic structure - Ti base - CAD/CAM system. The IPS e.max CAD ceramic structure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants. The compatible Implant systems, titanium bases and CAD/CAM systems are shown below: -Implant Systems: - Dentsply Sirona: AstraTech OsseoSpeed, Frialit/Xive (K130999, K013867) - BioHorizons Implant System: Internal Connection (K143022, K071638, K093321, K042429), - Osstem: TS Implant System (K121585) - Straumann: Tissue Level RN/WN (K061176) - Nobel Biocare: Branemark (K022562) - Zimmer: Tapered Screw-Vent (K061410) - Camlog: Camlog Screw-Line, Conelog Screw-Line, iSy (K083496, K113779, K133991) - CAD/CAM Systems: Sirona Dental CAD/CAM System (K181520) -Titanium Bases: Dentsply Sirona TiBase, Camlog TiBase

The IPS e.max® CAD Abutment Solutions- extra systems Device Description: which is the subject of this premarket notification is a modification to the IPS e.max CAD Abutment Solutions as previously cleared under K132209. The modifications represented in the subject device consist of the addition of 11 extra Ti-Bases to the 4 previously cleared Ti-Base compatibilities. IPS e.max CAD Abutment Solutions- extra systems is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. IPS e.max CAD Abutment Solutions is a system comprising IPS e.max CAD ceramic structure, Sirona TiBase and Sirona CAD/CAM System to design and fabricate the ceramic structure. The abutments being two-piece titanium base abutments are mated with a ceramic top-half, in which the assembly comprises the final-finished medical device of a patient-specific dental abutment. For the fabrication of IPS e.max CAD Abutment Solutions and depending on the CAD/CAM system used, the clinical situation is digitalized either by a direct intraoral scan or an indirect model scan. Updated material and TiBase library datasets relating to Sirona Dental CAD/CAM System with CEREC chairside software are obtained by download at: https://my.cerec.com. IPS e.max CAD Abutment Solutions are lithium disilicate blocks in various sizes. One side of the block is mounted to a mandrel that will be inserted into the spindle's clamping chuck of the grinding machine. The connection geometry to titanium bases is prefabricated, i.e. already included in the shipped block. The connection geometry fit select Titanium Bases as identified in the Indications for Use. The mesostructured is individually designed and milled using CAD/CAM Technology into the shape of a hybrid abutment or hybrid abutment crown. The device serves as the esthetic mesostructured which is extraorally cemented onto a Titanium Base. The two piece abutment is mounted onto the implant and fixed with a screw.

Helioseal F Plus is used to seal fissures, pits and foramina caeca.

Helioseal® F Plus is a light-curing, white shaded fissure sealant featuring fluoride release. Helioseal F Plus is supplied in either a syringe or cavifil delivery form. The fissure sealant is composed of dimethacrylates. In the handling technique, the dental professional will clean the enamel surface to be sealed, isolate the working field, conditioning is performed, a thorough rinse and dry to remove the conditioner, before the application of Helioseal F Plus to the tooth surface.

With its "Polywave" LED with broadband spectrum, Bluephase PowerCure is suitable for the polymerization of all light-curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.

Bluephase® PowerCure is an LED curing light that produces blue light. It is used for the polymerization of light-curing dental materials immediately in the oral cavity of patients. The intended place of application is in the dental practice, medical practice or in the hospital by the dentist or dental assistant. The curing light must only be operated by trained dental personnel. - The handpiece has the shape of a pen - Operational notes: 4 programs (3s, Turbo, High, PreCure) - Light source: Polywave LED - Power Source: Li-lons batterv

Conventional application (Light intensity ≤2,000 mW/cm2): - Restorations in the posterior region (Class I and II, including the replacement of individual cusps) - Class V restorations (cervical caries, root erosion, wedge-shaped defects) - Reconstructive build-ups - Restoration of deciduous teeth Light-curing using the 3sCure mode of Bluephase® PowerCure (Light Intensity 3,050 mW/cm2): - Restorations in the posterior region of permanent dentition (Class I and II, including the replacement of individual cusps) when light-cured from the occlusal aspect

Tetric® PowerFill is a light-curing radiopaque resin-based composite for the direct restorative treatment in posterior teeth. Tetric PowerFill cures with light in the wavelength range of 400-500 nm and can be applied in layers of up to 4 mm. The monomer matrix is composed of dimethacrylates (20-21 wt%). The fillers contain barium glass, ytterbium trifluoride, mixed oxide and copolymer (79-80 wt%). Additives, initiators, stabilizers and pigments are additional ingredients (< 1.0 wt%). While using the 3sCure mode of Bluephase Power-Cure (3.050mW/cm2), the material can be cured within 3 seconds. The material is available in syringes and cavifils.

With its "Polywave" broadband spectrum, Bluephase® Style 20i is suitable for the polymerization of all light curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.

Bluephase® Style 20i is an LED polymerization light that produces energy-rich blue plight. It is used for the polymerization of light-curing dental materials immediately at the dental unit. It consists of 1 Polywave LED in the probe. - The handpiece has the shape of a pen Operational notes: 2 programs (Turbo, High Power) Light source: Polywave LED Power source: Li-Po battery

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

IPS e.max Press will be used to press full ceramic pressed hybrid abutment crowns, or a customized hybrid abutment part which are luted on to recommended titanium connector abutments.