(114 days)
The Endomax™ is a cordless handpiece used primarily for root canal enlargement. This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.
The Endomax" Cordless Endodontic Handpiece has a number of substantially equivalent (SE) predicate devices. These predicate devices use the same technological methods to perform mechanical and rotary preparation of root canals with a cordless handpiece. A modular electrical system consisting of a drive handpiece, a rechargeable battery, contraangle head and a charging station are the main components of the predicate devices. The materials used in this device are composed of brass, silicon and Type II plastic as in the substantially equivalent devices.
The provided text is a 510(k) summary for the Endomax™ Cordless Endodontic Handpiece. It focuses on establishing substantial equivalence to predicate devices and provides regulatory information. Crucially, the document does not contain details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided input. The document is primarily a regulatory filing rather than a scientific study report.
The request asks for information that is not present in 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.