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Prime-Dent chemical cure composite restorative material is a direct filling dental composite used by licensed dentists to fill prepared cavities in teeth. Prime-Dent chemical cure composite restorative material is recommended for class III and class V restorations and for limited use in class I restorations in pre-molars and selected class IV restorations where esthetics are of primary importance.

Prime Dent chemical cure composite restorative material is a Bis GMA thermosetting resin with inorganic radiopaque barium borosilicate and glass quartz particles ranging from .04-10 micron average. The kit consists of 15gm catalyst paste, 15gm base paste, 3cc enamel bond catalyst, 3cc enamel bond base, and 7.5 ml etchant.

I am sorry, but the provided text does not contain the information required to answer your request. The text is a letter from the FDA regarding a 510(k) premarket notification for a dental restorative material, Prime-Dent Chemical Cure Composite. It discusses regulatory matters and indications for use but does not provide details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment for a device performance study.

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