(56 days)
DMC Composite High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, repair of porcelain restorations, and repair of composite restorations.
DMC Composite Low Viscosity is intended for Class I and II (base/liner), Class III and Class V restorations. Additional indications include pit and fissure sealant, repair of enamel defects, repair of porcelain restorations, blocking out of undercuts, minor occlusal build-ups in non-stress bearing areas and incisal abrasions.
DMC Composite is a light-cure resin composite offered in both high viscosity and low viscosity formulations, and is indicated for all caries classes. This product contains 82% filler by weight and is radiopaque.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a dental composite material, focusing on its substantial equivalence to previously marketed devices. It describes the device, its intended use, and the FDA's decision regarding its market clearance. It does not include details about specific performance studies or acceptance criteria that would typically be found in a clinical trial report or a detailed performance testing document.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.