(321 days)
The EM-07 is a cordless handpiece with apex localization capability, used for driving files in both continuous rotation and reciprocating mode during an endodontic procedure for enlargement of root canals, while monitoring the position of the endodontic file tip within the canal.
The EM-07 is a cordless handpiece with apex localization capability.
This document is an FDA 510(k) clearance letter for a dental handpiece, not a study report. It states that the device, EM-07 Cordless Endo Motor, has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The standard content of an FDA clearance letter focuses on regulatory approval rather than detailed performance study results.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report submitted to the FDA for review.
§ 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.