(140 days)
The device is intended for use in general dental applications, where high speed cutting is required; such as cutting a tooth for crown preparation, cavity preparation, removing metal crown or fillings.
This device uses a USA-patented, long proven check valve, a Non-Retraction Valve, in the water line of the handpiece to prevent the oral fluids, which could be contaminated, from being drawn into the handpiece spray port(s) of the handpiece. The contaminants could reach beyond the handpiece, but this check valve, as being installed in the handpiece body, prevents them from reaching beyond the handpiece.
Air Turbine Handpiece, MACH-Sigma (Σ) Ultra-Push
This document is a 510(k) clearance letter from the FDA for a dental handpiece. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations.
Therefore, I cannot provide the requested information based on 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.