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Dental core buildup material for use with 4th or 5th generation resin adhesive primer/bonding systems.

CORE PASTE is a dual-cure, radiopaque, filled, resin based core buildup material. The product will self-cure upon mixing equal parts of base and catalyst pastes. The setting time and resultant properties can be improved by further curing with a visible light dental curing unit. CORE PASTE is a high strength product ideally suited to buildup or replace lost tooth structure and to perform as a foundation restoration or core. It is used to build a damaged tooth to ideal anatomic form before it is prepared for a fixed dental prosthesis such as a crown. CORE PASTE is available in three shades: a blue material which serves to sharply contrast with tooth structure, a white opaque shade with similar clinical effects, and an esthetic A2 shade for optimal optical effects under esthetic translucent crown materials.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for a dental core buildup material named "CORE PASTE", detailing its intended use, description, and substantial equivalence to predicate devices, and the FDA's clearance letter. It does not include details on formal acceptance criteria or performance studies with the specific metrics you requested.

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