(90 days)
The device is intended for use where high speed such as 200,000 rpm is required in general dentistry with or without use of coolant; such as cutting a tooth for cavity and/or crown preparation and finishing, cutting and/or finishing of dentures, denture bases, crowns, inlays and metal plates. The device is driven by an electric micromotor or an air motor handpiece that has the ISO-3964 Coupling.
E-Type Speed Increaser Contra Angle, ES-95
This document is a 510(k) clearance letter from the FDA for a dental device. It does not contain information regarding acceptance criteria, a study proving performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot fulfill your request using the provided text. The document's purpose is to state that the device is substantially equivalent to legally marketed predicate devices and can now be marketed, not to detail the performance studies and criteria.
§ 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.