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# 4 Dental Device Performance Criteria Guides
- URL: https://www.fdaweb.com/4-dental-device-performance-criteria-guides/
- Published: 2024-09-27T12:00:00.000Z
- Updated: 2026-09-14T14:42:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157878

CDRH has issued four dental final guidances under its Performance Criteria for Safety and Performance Based Pathway program. They are:

1. [Dental Air-Powered Dental Handpieces and Air Motors](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/air-powered-dental-handpieces-and-air-motors-performance-criteria-safety-and-performance-based?ref=fdaweb.com)
2. [Dental Cements](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-cements-performance-criteria-safety-and-performance-based-pathway?ref=fdaweb.com)
3. [Dental Ceramics](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-ceramics-performance-criteria-safety-and-performance-based-pathway?ref=fdaweb.com)
4. [Dental Impression Materials](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-impression-materials-performance-criteria-safety-and-performance-based-pathway?ref=fdaweb.com)

CDRH says that under the pathway, device manufacturers planning to submit a 510(k) for these devices will have the option to use the performance criteria identified in the guidances to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.