(686 days)
Cutting and preparation of tooth structure, both enamel and dentin for all classes of cavity Cutting and preparation of tooth stracture, ooth onainer and/or abrasion of tooth surfaces and dental restorations to enhance adhesive restorative procedures.
Indications for use are identical to PrepStar™ by Danville Engineering Inc.
For Use by Dentists Only.
Disposable Dental Air Abrasion Handpiece
The provided text is a 510(k) premarket notification letter from the FDA to KIS Products, Inc. regarding their Disposable Dental Air Abrasion Handpiece. It states that the device is substantially equivalent to legally marketed predicate devices.
The letter does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
Therefore, I cannot provide the requested information. The document is solely an FDA clearance letter based on substantial equivalence, not a detailed report of performance testing or clinical studies with acceptance criteria.
§ 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.”