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High-speed Turbine Handpieces for Single Use are intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

The High-speed Turbine Handpieces for Single Use uses compressed air as power source which drives the wind wheel in the head to make drill rotating at very high speed for teeth cutting.

The proposed devices have 12 models difference includes: the size of head, methods of loading the drill, types of coupling, and shape of the shank.

The High-speed Turbine Handpieces for Single Use are single use device. The device is not software driven device, does not include drill.

This document is a 510(k) summary for a medical device called "High-speed Turbine Handpieces for Single Use." It does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria in the context of an AI/ML medical device.

The document discusses the substantial equivalence of a physical dental handpiece to predicate devices based on non-clinical tests and compliance with recognized standards. There is no mention of an algorithm, AI, or machine learning performance.

Therefore, I cannot provide the requested information from this document.

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