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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. In addition to above Indication for Use, we would like to emphasize, as a USA-patented, long proven dust shield mechanism, Clean-Head System, is used as an integral part of the turbine cartridge, that this device is able to substantially reduce bacterial contamination of the handpiece exhaust air lines to the dental unit.

Air Turbine Handpiece, Mach-Sigma Ultra Push

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental handpiece. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. Therefore, I cannot fulfill your request based on the given input.

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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.

Ask a specific question about this device