(511 days)
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.
Not Found
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.
§ 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.