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For use in prosthetic dentistry to create an all-ceramic prosthesis. - Ceramic for coverage of a zirconia substructure - Ceramic for coverage of a lithium disilicate substructure [CTE: 9.5~11.0×10-6/K (50-500°C)]

CERABIEN MiLai is a specific type of porcelain for dental restorations. The system consists of Powder, Paste and Liquids for powder/paste, to be applied utilizing layering technique and baked onto a ceramic frame of zirconia (ZrO2) or different lithium disilicate glasses.

KATANA Zirconia ONE For IMPLANT is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. For the SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. KATANA Zirconia ONE For IMPLANT is used in combination with the TiBase and Sirona Dental CAD/CAM System. KATANA Zirconia ONE For IMPLANT cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants. Compatible implant systems and TiBase are as follows.

The KATANA Zirconia ONE For IMPLANT mesostructure material (conforming to ISO 6872:2015) is a pre-sintered zirconia block to be used as the ceramic mesostructure component of a two-piece titanium base abutment. KATANA Zirconia ONE For IMPLANT is compatible with the specified TiBase and the CAD/CAM component of the Sirona Dental CAD/CAM system (K193408, K200191) as identified in the Indications for Use. This device is further processed by the trained professional to make individually designed mesostructure that are milled into the desired shape of a hybrid abutment or hybrid abutment crown. The Zirconia block has identical composition as our own previously cleared reference device, KATANA Zirconia Block (K190436) under product code "EIH". The mesostructure material of KATANA Zirconia ONE For IMPLANT is available in shades, A1, A2, A3, A3.5, B1, B2, C1, C2, D2 and NW for flexibility and application variety to meet individual patient needs. The mesostructure material of KATANA Zirconia ONE For IMPLANT is available with one block size and two sizes of access hole, which is small (S) and large (L). The abutment must be sterilized after the cementation of the CAD/CAM patient matched mesostructure on the pre-manufactured titanium base component. PANAVIA SA Cement Universal (K183537) is used as the cement to set the mesostructure material to TiBase when the mesostructure material of the subject device set to TiBase prior to sterilization. Dentsply Sirona has issued a letter of authorization indicating that the subject mesostructure material of the subject device can be selected in combination with the CAD/CAM system. Kuraray Noritake Dental and Dentsply Sirona have a business agreement for adding this new material to the Sirona CAD/CAM system. Kuraray Noritake Dental has worked with Dentsply Sirona to implement their new material into the Sirona CAD/CAM system libraries. KATANA Zirconia ONE For IMPLANT which is the subject of this premarket notification consists of: - Sirona Dental CAD/CAM System with CEREC Chairside Software or with inLab Software - Sirona TiBase - . KATANA Zirconia ONE mesostructured blocks

- [1] Direct restorations using light-cured composite resin - [2] Sealing of a prepared cavity or abutment tooth as a pretreatment for indirect restorations - [3] Treatment of exposed root surfaces - [4] Treatment of hypersensitive teeth - [5] Intraoral repairs of fractured restorations - [6] Post cementation and core build-ups - [7] Cementation of indirect restorations

CLEARFIL Universal Bond Quick 2 consists of BOND and K-ETCHANT Syringe. BOND is a light-cure bonding agent that allows for the treatment of dentin, enamel, and prosthetic materials. Depending on the indication, BOND is used as self-etching or with K-ETCHANT Syringe for selective enamel etching or total-etching procedures. BOND is intended to be used for both direct and indirect restorations. CLEARFIL DC Activator activates the dual-curing mechanism of BOND; however, the addition of CLEARFIL DC Activator to the adhesive is not required when using BOND with CLEARFIL DC CORE PLUS, self-adhesive resin cements manufactured by Kuraray Noritake Dental Inc. (Kuraray's self-adhesive cements, e.g. PANAVIA SA Cement Universal) or PANAVIA Veneer LC. K-ETCHANT Syringe is an etching gel that consists of 35 % phosphoric acid aqueous solution and colloidal silica.

Esthetic Colorant is used for coloring pre-sintered zirconia structures for the fabrication of all-ceramic restorations.

Esthetic Colorant, a colorant with a zirconia structure, is a dilute aqueous solution of transition metal salts and lanthanoid metal salts and enables appropriate color adjustment when combined with a pre-sintered zirconia structure such as KATANA Zirconia (K143439). Esthetic Colorant colors the pre-sintered zirconia structure by applying it with a metal-free brush. The structure is then dried and then sintered at temperatures above 1400°C. Sintering welds the coloring components in Esthetic Colorant, making it possible to adjust the color shade of the zirconia structure. Esthetic Colorant has 12 shades in bottle size (12 ml). In addition, Esthetic Colorant can only be used by professional technicians in the field of dentistry.

For use in prosthetic dentistry to create an all-ceramic prosthesis. - Ceramic for coverage of a zirconia substructure - Ceramic for coverage of a lithium disilicate substructure [CTE: 10.2-10.5×10-6/K (50-500°C)]

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Cementation of ceramic and composite inlays, onlays and laminate veneers with less than 2mm thickness

PANAVIA Veneer LC is a light-cure adhesive resin cement system. It consists of the light-cure cement paste (PANAVIA Veneer LC paste), CLEARFIL CERAMIC PRIMER PLUS, K-ETCHANT Syringe, and PANAVIA V5 Try-in Paste. CLEARFIL Universal Bond Quick or PANAVIA V5 Tooth Primer can be chosen for tooth treatment. The cement paste is a light-cure, resin based material which provides color stability and has radiopacity equal to or greater than 1mm aluminum. It is indicated for inlays, onlays and laminate veneer restorations made of ceramic and composite resin. It is supplied in Kuraray's ergonomic syringe and dispensed via an angled applicator tip (16G) into an inlay cavity or onto an onlay or a laminate veneer. It is available in 4 shades; Universal (A2), Clear, Brown (A4) and White. It is classified as a Type 2 and Class 2 (Group 1) material by ISO 4049. Shade adaptation is available to check by PANAVIA V5 Try-in Paste before cementation. This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device. We are seeking clearance for PANAVIA Veneer LC paste in this submission. Concerning Try-in Paste which is included as components of the PANAVIA V5, CLEARFIL Universal Bond Quick, CLEARFIL CERAMIC PRIMER PLUS and K-ETCHANT Syringe, the specification of those 4 components were omitted for the reasons set forth below. We already have had 510(k) clearance of Try-in Paste of PANAVIA V5(510(k) Number: 150704), CLEARFIL Universal Bond Quick (510(k) Number: 161042), CLEARFIL CERAMIC PRIMER PLUS (510(k) Number: 150703) and K-ETCHANT Syringe (510(k) Number: 133078).

For use in prosthetic dentistry to create a Porcelain prosthesis on a frame of dental alloy.

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CLEARFIL MAJESTY ES Flow is indicated for the following restorative applications: - [1] Direct restorations for all cavity classes, cervical lesions (e.g. root surface caries, v-shape defects), tooth wear, and tooth erosion - [2] Cavity base / liner - [3] Correction of tooth position and tooth shape (e.g. diastema closure, tooth malformation) - [4] Intraoral repair of fractured restorations - [5] Cementation of ceramic and composite inlays, onlays and veneers with less than 2mm thickness

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- [1] Cleaning of contaminated glass ceramic, zirconia, resin restorations, metal restorations and fiber post after intraoral try-in. - [2] Cleaning for contaminated prepared tooth (cavity, root canal and tooth abutment), and implant abutment

This subject device is a dental cleaning agent suitable for non-abrasive cleaning of the bonding surfaces of prosthetic restorations after intraoral try-in. It is also suitable for cleaning a contaminated prepared cavity, root canal, and tooth/ implant abutment. It is used in helping to achieve optimal adhesive results.

KATANA Zirconia Block is used for the fabrication of the ceramic restorations (frameworks, FCZ crowns, FCZ bridges (14Z L only), inlays, onlays and veneers).

The subject device, KATANA Zirconia Block is a pre-sintered zirconia block composed of yttrium stabilized zirconia, which is designed for CEREC milling systems. The subject device is meant to be end-user sintered after milling for the fabrication of dental restorations. KATANA Zirconia Block STML has 3 sizes (12Z, 14Z and 14Z L) and has 14 shade variations: (A1, A2, A3, A3.5, A4, B1, B2, B3, C1, C2, C3, D2, D3, NW). KATANA Zirconia Block ST has 1 size: (12Z) and has 1 shade variation: (CL). STML consists of 4 gradated shade layers and ST is mono color. They are classified as a Type II and Class 4a) material by ISO 6872.