(18 days)
The device is a dc electric micromotor driven by the battery power pack control device with emphasis in mobility to visit schools, nursing homes, house calls, and for emergency need.
It is intended for use in general dental applications for light work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, and endodontic treatment, with use of straight, right-angle or contra-angle ISO E-type attachment.
The device is a dc electric micromotor driven by the battery power pack control device with emphasis in mobility to visit schools, nursing homes, house calls, and for emergency need.
This document is a 510(k) clearance letter from the FDA for a dental device called "Handy-Mate," issued on March 19, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.
This document does NOT contain information about acceptance criteria, device performance, sample size, ground truth establishment, or any study details. It is a regulatory clearance, not a technical performance report. Therefore, I cannot extract the requested information from the provided text.
§ 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.