(89 days)
The Endo-Eze 965A UL Contra-Angle Handpiece is designed to be used with the Endo-Eze Shaping Files and all other files with handle diameters up to 2.35 mm. The Endo-Eze A25 UL Air Motor and Handpiece is a mechanical device to be used by dentists performing root canal treatment.
The Endo-Eze A25 UL Air Motor and Handpiece is a mechanical device. The Endo-Eze 965A UL Contra-Angle Handpiece is designed to be used with the Endo-Eze Shaping Files and all other files with handle diameters up to 2.35 mm.
The provided text is a 510(k) premarket notification letter from the FDA for the "Endo-Eze Motor and Handpiece." This document details the FDA's decision regarding the device's substantial equivalence to a predicate device, allowing it to be marketed. However, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the device was cleared based on substantial equivalence, not necessarily on a new clinical study demonstrating performance against specific acceptance criteria.
Therefore, I cannot fulfill your request using the provided input. The document does not contain the detailed study information you are asking for.
§ 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.