(87 days)
Metal Opaquer is a light activated (photo initiated via free radical polymerization) opaquing composite material, designed for use as a tooth or white colored composite material to cover metal and create more aesthetically pleasing restorations.
Metal Oapquer is a composite material which, when utilized properly, masks the metal appearance of dental implants, abutments or restorations with a tooth colored composite layer. Metal Opaquer is compatible with all other methacrylate based dental materials.
Metal Opaquer is a light activated (photo initiated via free radical polymerization) opaquing composite material, designed for use as a tooth or white colored composite material to cover metal and create more aesthetically pleasing restorations.
Metal Oapquer is a composite material which, when utilized properly, masks the metal appearance of dental implants, abutments or restorations with a tooth colored composite layer. Metal Opaquer is compatible with all other methacrylate based dental materials.
The provided text is a 510(k) premarket notification letter from the FDA to Apex Dental Materials, Inc. for a device named "Metal Opaquer." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or adjudication methods. It is an administrative letter confirming substantial equivalence to a predicate device and outlining regulatory responsibilities.
Therefore, I cannot provide the requested information based on the input text. The document does not describe a study proving the device meets acceptance criteria.
§ 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.