(430 days)
Dental High-speed Turbine Handpiece is intended for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Dental Low-speed Turbine Handpiece is intended for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Not Found
This document is a 510(k) clearance letter for a Class I dental handpiece, and does not contain information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria. The information provided in the prompt relates to general regulatory requirements for medical devices, not the specific performance evaluation of an AI-powered diagnostic or treatment device.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves a device meets them based on the provided text, as the text is a regulatory clearance for a physical dental tool, not an AI/ML device.
§ 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.