(87 days)
A dental high-speed handpiece is designed for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Not Found
The provided documents describe an FDA 510(k) clearance for the Synea-HS High-Speed Handpiece (K992011). However, the documents do not contain any information about acceptance criteria, device performance testing, study design, sample sizes, expert involvement, or any of the detailed information requested in the prompt.
The letter from the FDA (dated September 10, 1999) only states that the device is "substantially equivalent" to legally marketed predicate devices for the indications for use listed. It does not provide any data from clinical trials, performance studies, or details about the acceptance criteria used for such studies.
Therefore, I cannot answer the specific questions posed in the prompt based on the provided text. The requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, etc., is not present in these FDA clearance letters.
§ 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.