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Dental High-speed Turbine Handpiece is intended for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Dental Low-speed Turbine Handpiece is intended for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

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This document is a 510(k) clearance letter for a Class I dental handpiece, and does not contain information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria. The information provided in the prompt relates to general regulatory requirements for medical devices, not the specific performance evaluation of an AI-powered diagnostic or treatment device.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves a device meets them based on the provided text, as the text is a regulatory clearance for a physical dental tool, not an AI/ML device.

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