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Post cementation and core build-up

The subject device is a dual-cured (light-cured with self-curing property), radiopaque two-component core build-up material supplied in an automix delivery system which can mix equal amount of two components, and is available in two shades, Dentin and White.

[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 prosthetic restorations made of porcelain, ceramic or composite resin [6] Surface treatment of dental posts [7] Post cementation and core build ups using dual cured composite resin CLEARFIL DC CORE PLUS [8] 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.

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 easy handling and placement. It is classified into tooth shade resin material (21 CFR section 872.3690, Product code: EBF ) according to 21 CFR section 872 since it is composed of materials such as 2,2'-Bis-[p-( Y -methacryloxy- 3 -hydroxypropoxy) phenyl] propane (Bis-GMA). According to the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, res orative and luting materials", this device is classified into the following: -Type 1: polymer-based filling and restorative materials; - Class 2: materials whose setting is effected by light; - Group 1: materials whose use requires the energy to be applied intra-orally.

CLEARFIL MAJESTY Flow is indicated for the following restorative applications: - Direct restorations for anterior and posterior teeth (Class I III, V cavities, cervical caries, root erosion) - Cavity base / liner - Intraoral repairs of fractured crowns / bridges / composite resin

CLEARFIL MAJESTY Flow is a flowable, radiopaque restorative composite resin which provides true to life color matching, high polish ability and excellent physical properties, making ideal for both anterior and posterior restorations. CLEARFIL MAJESTY Flow can be used alone or together with CLEARFIL AP-X and CLEARFIL MAJESTY Esthetic. It is classified into tooth shade resin materia" (21 CFR section 872.3690, Product code: EBF ) according to 21 CFR § 872 since it is composed of materials such as methacrylate monomers.

SURFACE COAT is used to glaze/polish following restorations: - Direct and indirect composite resins - Acrylic provisional crowns and bridges - Acrylic appliances - Glass ionomers and resin-modified glass ionomers

SURFACE COAT is a single-component, light-cure resin glaze material that provides a clear and smooth surface, consisting of a multi-functional acrylate monomer that provides excellent durability and may reduce or even eliminate the need for manual polishing. SURFACE COAT has virtually no surface oxygen inhibition layer.

PANAVIA F is indicated for the following applications: Cementation of metal crowns and bridges, inlays and onlays. Cementation of porcelain crowns, inlays and onlays. Cementation of to composite resin crowns, inlays and onlays Cementation of adhesion bridges and splints Cementation of metal cores and prefabrication posts Bonded amalgam restorations

PANAVIA F is classified into dental cement, CFR 21 Section 872.3275, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for cementation of dental devices such as crowns or bridges. PANAVIA F is a resin based cement cured chemically and by visible light activation, and the improved device of PANAVIA 21. There are two major improvements; the curing method and introduction of the metal adhesion primer (ALLOY PRIMER, K974089). This device consists of Paste (A and B pastes), ED Primer (Liquids A and B), ALLOY PRIMER, Oxyguard II, and accessories.

Color characterization for: 1) Jacket crown 2) Facing crown 3) Inlay and onlay

CHROMA ZONE COLOR STAIN is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for laboratory fabrication of jacket crown, facing crown, inlay and onlay restorations. CHROMA ZONE COLOR STAIN consists of 11 Stain Pastes, the Clear Paste and accessories. These components are similar to that of stain materials of the products in the paragraph 4 of this summary. In general, resin-based crown and bridge materials consists of body resin such as transparent, enamel and dentin, opaque resin, stain and accessories. CHROMA ZONE COLOR STAIN is a stain material for color characterization to be used in conjunction with resin-based crown and bridge materials.

This device is used for the following indications. Each indication is same to that of similar products. 1) Jacket crown 2) Facing crown 3) Inlay and onlay

ESTENIA is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers › intended to be used for laboratory fabrication of jacket crown, facing crown, inlay and onlay restorations. ESTENIA consists of Body Resin, Opaque Resin, Opaque Primer, Modeling Liquid, Add-on Primer, Air-Barrier Paste and accessories.

1) Direct filling restorations using light-cure or chemical-cure composite resin 2) Bonded amalgam restorations 3) Treatment of hypersensitive and/or exposed root surfaces 4) Cavity sealing as a pretreatment for indirect restorations 5) Intraoral repairs of facing crowns using light-cure composite resin 6) Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement

CLEARFIL LINER BOND 2V is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. PROTECT LINER F is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of material such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth. CLEARFIL PORCELAIN BOND ACTIVATOR was permitted to marketed under its 510 (k) notification submission. This product is similar and substantially equivalent in design, composition and function to the similar products which are identified in the paragraph 4 of this summary; all of which are safe, effective and beneficial.