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3MIM Clinpro™ Clear 2.1% Sodium Fluoride Treatment is indicated for the treatment of hypersensitive teeth.

3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment is an aqueous fluoride coating that is applied topically to the tooth surfaces for the treatment of hypersensitive teeth. The product is sweetened with xylitol and sucralose. Clinpro 2.1% Sodium Fluoride Treatment contains 9,500 ppm fluoride and added calcium and phosphate. 3M Clinpro Clear 2.1% Sodium Fluoride Treatment uses the L-Pop™ unit dose dispensing system designed by 3M. Each L-Pop contains 0.5 ml (0.5 grams) of the coating and is offered in mint and melon flavors and a flavorless version.

3M VitCal Liner/Base is indicated for lining and basing applications under dental restorations. 3M VitCal Liner/Base is also indicated for direct pulp capping.

3M VitCal liner/base is a two-part paste/paste, light-cured system. The paste/paste materials are contained in a Micro-Mix Syringe Dispensing System. This dispensing system provides simultaneous dispensing and mixing of each component for a consistent mix and direct application into the mouth. The composition is a combination of a resin-modified glass ionomer and calcium-based material. The first paste contains a radiopaque fluoro-aluminosilicate glass and calcium filler. The second paste contains a modified polyalkenoic acid. VitCal liner/base provides the major benefits of glass ionomer cements including adhesion to the tooth structure and sustained fluoride release. Additionally, VitCal linerbase offers a high pH environment and a combination of a prolonged working time with an on-demand set time achieved by light curing.

Permanent cementation of pediatric crowns: • Stainless Steel crowns • Zirconia crowns • 3M™ Pediatric Esthetic Crowns

3MTM RelyX™ Pediatric Resin Modified Glass Ionomer Cement is a radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement. RelyX Pediatric Cement is intended for the cementation of preformed pediatric crowns made of stainless steel, zirconia, and resin composite material. RelyX Pediatric Cement consists of a base paste and a catalyst paste packaged in the Automix delivery system for direct delivery in consistent mix ratios. The mixing tip attachment offers convenience over traditional hand mixed cement systems and delivers consistent mix ratios. The cement is available in a white shade. The Automix syringe contains 8.5 g of cement material. The product provides both selfcuring and light curing mechanisms which makes it uniquely versatile for the cementation of different restorative materials.

· Direct anterior and posterior restorations (including occlusal surfaces) · Core build-ups · Splinting · Indirect restorations including inlays, onlays, and veneers

3MTM FiltekTM Universal Restorative, is a visible-light activated, restorative composite optimized to create esthetic anterior and posterior restorations. This material provides excellent strength and low wear for durability and improved esthetics with higher level of visual opacity. The shades are body like opacity enabling up to a 2mm depth-of-cure. The pink opaquer can be placed in 1mm thick increments. All shades are radiopaque. Filtek Universal Restorative is offered in the following shades: A1. A2, A3. A3.5. A4, B1. B2, D3. XW, and PO. The pink opaque shade option can be used to mask discolored or stained tooth structure. Filtek™ Universal Restorative is packaged in traditional syringes, for dispensing restorative on a pad outside the mouth, and single-dose capsules for dispensing restorative intraorally. The capsules are dispensed using the 3M ESPE Restorative Dispenser. Capsules may be warmed up to 70°C/158°F for one hour in a commercial warmer prior to use.

- Direct anterior and posterior restorations (including occlusal surfaces) - Base/liner under direct restorations - Core build-ups - Splinting - Indirect restorations including inlays, onlays and veneers - Restorations of deciduous teeth - Extended fissure sealing in molars and premolars - Repair of defects in porcelain restorations, enamel, and temporaries

3MTM ESPETM FiltekTM Bulk Fill Posterior Restorative material is a visible-light activated, restorative composite optimized to create posterior restorations simpler and faster. This bulk fill material provides excellent strength and low wear for durability. The shades are semi-translucent and low stress curing, enabling up to a 5 mm depth-ofcure. With excellent polish retention, Filtek™ Bulk Fill Posterior Restorative is also useful for anterior restorations that call for a semi-translucent shade. All shades are radiopaque. Filtek™ Bulk Fill Posterior Restorative is offered in A.I. A2. A3. B1. and C2 shades. Filtek™ Bulk Fill Posterior Restorative is applied to the tooth following use of a methacrylate-based dental adhesive, such as manufactured by 3M™ ESPETM. which permanently bonds the restoration to the tooth structure. Filtek™ Bulk Fill Posterior Restorative is packaged in traditional syringes, for dispensing restorative on a pad outside the mouth, and single-dose capsules for dispensing restorative intraorally. The capsules are dispensed using the 3M ESPE Restorative Dispenser.

- Base under Class I and II direct restorations . - Liner under direct restorative materials . - . Pit and fissure sealant - Restoration of minimally invasive cavity preparations (including small, ◆ non stress-bearing occlusal restorations) - Class III and V restorations . - . Undercut blockout - Repair of small enamel defects . - Repair of small defects in esthetic indirect restorations . - Repair of resin and acrylic temporary materials . - As a core build-up where at least half the coronal tooth structure is . remaining to provide structural support for the crown

Filtek™ Bulk Fill Flowable Restorative, is a low viscosity, visible-light activated, radiopaque, flowable. This low stress flowable material is semitranslucent enabling a 4mm depth of cure. The restorative is packaged in capsules and syringes. The shades offered with Filtek™ Bulk Fill flowable are U (Universal), A1, A2, and A3. Filtek™ Bulk Fill flowable contains bisGMA, UDMA, bisEMA(6) and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particle sizes from 0.1 to 5.0 microns and zirconia/silica with a particle size range of 0.01 to 3.5 µm. The inorganic filler loading is approximately 64.5% by weight (42.5% by volume). A dental adhesive is used to permanently bond the restoration to the tooth structure. Filtek™ Bulk Fill Flowable Restorative is a modification of predicate device Filtek™ Supreme Ultra Flowable Restorative. The formulation was modified to increase depth of cure, while decreasing polymerization shrinkage stress.

This device is intended for use as a dental cement. RelyX™ Luting Plus Automix (Lexus-2) is indicated for Luting: - Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass ionomer core build ups; - Luting metal inlays, onlays or crowns; - Luting pre-fabricated and cast post cementation - Luting orthodontic appliances - Luting crowns made with all-alumina or all zirconia cores such as Procera® AllCeram

3M™ ESPE™ RelyX™ Luting Plus Automix (Lexus-2) is a radiopaque, fluoride-releasing, resinmodified glass ionomer luting cement. It is self-curing with an option for tack light curing of excess cement. RelyX Luting Plus Automix (Lexus-2) consists of a base (Paste A) and catalyst (Paste B) packaged in an automix (dual barrel) syringe. The dual barrel syringe dispenses paste A and Paste B. The cement is available in a white shade.

The product is indicated for inlays, onlays, veneers, and full crown restorations, including crowns on implants.

The product is a strong, wear-resistant and highly esthetic mill block that provides a fast and easy-to-use alternative to porcelain blocks for milling CAD/CAM indirect restorations. The material is specially processed to enhance its properties for use in CAD/CAM milling procedures.

- Treatment of hypersensitive teeth - Use on exposed dentin and root sensitivity - Under temporary restoratives and cements where post-operative sensitivity is of concern

Vanish Varnish is a topically applied, flavored cavity varnish containing sodium fluoride and calcium phosphate in a rosin based preparation. The varnish is an insoluble viscous liquid that forms a film on tooth surfaces.

1. Lining and basing applications under composite, amalgam, ceramic or metal restorations. 2. Treatment of exposed root surface sensitivity 3. Site specific protective coating for newly erupted teeth and other tooth surfaces including non-cavitated lesions

GILB-2, Glass Ionomer protective coating is classified as Dental Cement (21 C.F.R§872.3275) because it is a device intended to provide protection as a cavity liner/basing material as well as in treatment of exposed root surfaces hypersensitivity. GILB-2 is a site specific protective coating for newly erupted teeth and other tooth surfaces including non-cavitated lesions. GILB-2 is a two part liquid/paste system. The liquid/paste materials are contained in the Clicker™ Dispensing System manufactured by 3M ESPE. This dispensing system provides simultaneous dispensing of each component for a consistent mix. The chemical composition is similar to predicate glass ionomer dental cement devices. The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405. The performance testing results provided in the submission confirms the performance as substantially equivalent to the predicate devices with common indications.