(85 days)
A dental low-speed handpiece is designed for removing carious material, cavity and crown preparation, excess filling material, root canal preparations, finishing tooth preparations, restorations and polishing teeth.
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The provided text is a 510(k) clearance letter from the FDA for a dental low-speed handpiece. It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in the 510(k) submission itself, which is not available here.
Therefore, I cannot provide the requested information based on the given input.
§ 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.