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- [1] Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal - [2] Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments - [3] Cementation of metal cores, resin cores, metal posts or glass fiber posts

PANAVIA SA CEMENT Handmix is a dual-curc (light- and/or self-cure), radiopaque self-adhesive resin cement for porcelain, ceramic, composite resin and metal restorations. It is intended for the following indications: (1) Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal (2) Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments (3) Cementation of metal cores, resin cores, metal posts or glass fiber posts It is classified into dental cement (21 CFR section 872,3275. Product code: EMA ) according to 21 CFR§872 since it is composed of various materials other than zinc oxide-eugenol. Physical and mechanical properties of the subject device were evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials). According to ISO 4049: 2009, the subject device is classified into the following: Class 3: materials that are cured by the application of external energy and also have a self-curing mechanism present (This product contains the adhesive monomer. ISO 4049:2009 does not cover the polymer-based luting materials that have an adhesive component within the structure of the material. However, we tested referring to this standard.)

- [1] Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal - [2] Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments - [3] Cementation of metal cores, resin cores, metal posts or glass fiber posts

PANAVIA SA CEMENT Automix is a dual-cure (light- and/or self-cure), radiopaque self-adhesive resin cement for porcelain, ceramic, composite resin and metal restorations. It is supplied in an automix delivery system which can mix equal amount of two components.

- [1] Direct restorations using light cured composite resin - [2] Cavity sealing as a pretreatment for indirect restorations - [3] Treatment of exposed root surfaces - [4] Intraoral repairs of fractured restorations made of porcelain, ceramic or composite resin - [5] Surface treatment of non-precious metal posts - [6] Post cementation and core build·ups using dual·cured composite resin CLEARFIL DC CORE PLUS - [7] Core build-ups using light-cured composite resin

The subject device is a single-component. light-cured bonding agent that allows simultaneous treatment of both dentin and enamel. A single dose of it comes in a container with an applicator tip for fast, direct placement into the cavity.

1) Direct restorations for anterior and posterior teeth (Class I - V cavities) 2) Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.) 3) Intraoral repairs of fractured crowns/bridges

CLEARFIL MAJESTY Posterior is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring casy handling and placement.

1) Direct restorations for anterior and posterior teeth (Class I V cavities) 2) Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.) 3) Intraoral repairs of fractured crowns/bridges

CLEARFIL MAJESTY Posterior PLT (PLT:Pre-loaded tip) is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. CLEARFIL MAJESTY Posterior PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity. In this application, we have precisely defined the amount of dl-Camphorquinone and N.N-Diethanol-p-toluidine (DEPT) contained in CLEARFIL MAJESTY Posterior PLT in range of chemical composition shown in the original application in order to improve its sensitivity to ambient light.

1) Cementation of crowns, bridges, inlays and onlays made of conventional porcelain, ceramic, hybrid ceramics, composite resin or metal 2) Cementation of metal cores, resin cores, metal posts or glass-fiber posts

CLEARFIL SA CEMENT is a dual-cure (light-and/or self-adhesive resin cement for conventional porcclain, ceramic, hybrid ceramics (e.g. ESTENIA C&B), composite resin and metal restorations. It is classified into dental cement (21 CFR section 872.3275, Product code: EMA ) according to 21 CFR § 872 since it is composed of various materials other than zinc oxide-eugenol. According to the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials", this device is classified into the following: Class 3: materials that are cured by the application of external energy and also have a self-curing mechanism present

1) Direct restorations for anterior and posterior teeth (Class I - V cavities) 2) Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.) 3) Intraoral repairs of fractured crowns/bridges

CLEARFIL MAJESTY Posterior PLT (PLT: Pre-loaded tip) is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. CLEARFIL MAJESTY Posterior PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity. CLEARFIL MAJESTY Posterior PLT, the applicant device, is substantially the same as CLEARFIL MAJESTY Posterior, the predicate device where the only difference is the container form; the applicant device comes in tips while the predicate device is filled in syringes. The tips used in the applicant device are the same as those used in CLEARFIL AP-X PLT, the predicate device, except for the color. The applicant device is substantially equivalent to the predicate devices.

CLEARFIL MAJESTY Esthetic PLT is indicated for the following restorative applications: - 1) Direct restorations for anterior and posterior teeth (Class I V cavities) - 2) Direct veneers - 3) Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.) - 4) Intraoral repairs of fractured crowns/bridges

CLEARFIL MAJESTY Esthetic PLT (PLT: Pre-loaded tip) is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. CLEARFIL MAJESTY Esthetic PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity. CLEARFIL MAJESTY Esthetic PLT, the applicant device, is substantially the same as CLEARFIL MAJESTY Esthetic, the predicate device where the only difference is the container form; the applicant device comes in tips while the predicate device is filled in syringes. The tips used in the applicant device are the same as those used in CLEARFIL AP-X PLT, the predicate device. Therefore, the applicant device is substantially equivalent to the predicate devices.

1) Etching the enamel and dentine for adhesive restorations.

K-ETCHANT GEL is an etching agent consists of 40 % phosphoric acid aqueous solution and colloidal silica. It is classified into resin tooth honding agent, 21 CFR Section 872.3200, because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration.

1) Surface treatment of porcelain, ceramics, hybrid ceramics or composite resin 2) Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics, hybrid ceramics or composite resin

CLEARFIL CERAMIC PRIMER is a silane-coupling agent that provides an enhanced adhesive surface to porcelain, ceramics, hybrid ceramics or composite resin.