(83 days)
This handpiece is to be used for intra and extra orally to cut, shape, grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth.
Microtech Push Button Handpiece
The provided text is a government letter from the FDA regarding the clearance of a medical device, the "Microtech Push Button Handpiece." It does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
The letter is a 510(k) premarket notification acceptance, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. This type of clearance typically relies on demonstrating equivalence to existing devices rather than new performance studies against specific acceptance criteria.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving their fulfillment based on this document. The document primarily focuses on regulatory approval and classification.
§ 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.