(49 days)
For use as a tooth shade resin material in dental procedures
The product is a tooth shade resin material for use in dental restorations. It may be used with Tokuyama's Mac Bond II or other brands of similar bonding agents. It is not intended for DTC use. It contains materials that are common in dental use and pose no health hazard when used according to directions.
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 appears to be a 510(k) summary and an FDA clearance letter for a dental resin material, focusing on its substantial equivalence to a predicate device rather than performance metrics and validation studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
§ 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.