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Dental high speed handpiece: Is intended for removing carious material, reducing hard tooth structure, cavity and crown preparations, removal of fillings, finishing tooth preparations, restoration and polishing teeth. The device is designed for use by a trained professional in the field of general dentistry. Dental low speed handpiece: Is intended for preparing dental cavities and crown for restorations, and teeth cutting, restorations and polishing teeth. The device is designed for use by a trained professional in the field of general dentistry.

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The provided document is a 510(k) premarket notification letter from the FDA for a Dental high speed handpiece and Dental low speed handpiece. This document primarily focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria for an AI/CAD-based medical device.

Therefore, the information required to answer your specific questions about acceptance criteria and a study proving a device meets them (especially in the context of an AI/CAD-based device) is not contained within these documents.

The document states:

• Device Name: Dental high speed handpiece, Dental low speed handpiece
• Regulation Number: 21 CFR 872.4200
• Regulation Name: Dental Handpiece And Accessories
• Regulatory Class: Class I
• Product Code: EFB

This is for a mechanical dental instrument, not a software or AI-driven diagnostic device. The approval is based on demonstrating substantial equivalence in design, materials, and functional principles to existing predicate devices, not on a performance study against specific acceptance criteria for diagnostic accuracy or clinical outcomes.

To provide a comprehensive answer to your questions, a different type of FDA submission document (e.g., a PMA, or a more detailed 510(k) submission for an AI/CAD device that includes clinical study data) would be needed.

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

Ask a specific question about this device