(91 days)
Ax's Endo® handpieces are intended to hold burs or other tools and to transmit power to these via a motor.
Ax's Endo® handpieces are intended to hold burs or other tools and to transmit power to these via a motor.
This is an FDA 510(k) clearance letter for the Ax's Endo® dental handpiece. This document is a regulatory approval, not a scientific study report. Therefore, it does not contain information regarding acceptance criteria for a device's performance based on a study, nor does it describe a study proving the device meets particular criteria.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. This means the FDA found that the new device is as safe and effective as a legally marketed device that is not subject to PMA.
Therefore, I cannot fulfill your request for the specific points about acceptance criteria and a study from the provided document.
§ 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.