(349 days)
AeroPro™ Cordless Prophy System is a high performance cordless prophylaxis handpiece with a centrol button for use with disposable prophylaxis angles to perform cleaning and polishing procedures on teeth.
AeroPro™ Cordless Prophy System is a high performance cordless prophylaxis handpiece with a centrol button for use with disposable prophylaxis angles to perform cleaning and polishing procedures on teeth.
The provided text is an FDA 510(k) clearance letter for the AeroPro™ Cordless Prophy System. It indicates that the device has been found substantially equivalent to a predicate device. However, this document does not contain information regarding specific acceptance criteria, performance data, or studies of the type requested (e.g., sample size, ground truth, expert qualifications, MRMC studies) as these are typically found in the 510(k) summary or detailed submission, not the clearance letter itself.
Therefore, I cannot provide the requested information from the given text. The text only describes the device's indications for use and the regulatory clearance process.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.