(603 days)
OptiComp is a light cured hybrid dental restorative composite material used for direct restorations in all classes of cavities, including veneers and incisal edge repairs, and indirect anterior restorations, including inlays, onlays, and veneers.
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria for the OptiComp device. The document is an FDA 510(k) clearance letter, which primarily focuses on regulatory approval and substantial equivalence to legally marketed predicate devices. It outlines the device's indications for use and general regulatory requirements but does not detail specific performance studies or their results.
§ 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.