(77 days)
Cutting and Preparation of tooth structure, both enamel and dentin for all classes of cavity preparations. Removal of composite restorations. For roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures.
Indications for use are identical to Microetcher AP/PrepStar™ by Danville Engineering Inc.
For Use by Dentists Only.
Not Found
I apologize, but the provided text only contains an FDA 510(k) clearance letter for the "Groman PrepMaster™" device. This letter primarily focuses on the regulatory approval and substantial equivalence to a predicate device.
It does not contain any information regarding specific acceptance criteria, study designs, sample sizes, expert qualifications, or performance metrics that would be necessary to answer your questions about the device's performance study.
Therefore, I cannot provide the requested table or describe the study that proves the device meets acceptance criteria based on the given input.
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”