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# Performance Criteria for Endosseous Dental Implants
- URL: https://www.fdaweb.com/performance-criteria-for-endosseous-dental-implants/
- Published: 2024-10-11T12:00:00.000Z
- Updated: 2026-09-14T14:43:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157970

FDA has posted a [final guidance](https://www.fda.gov/media/182616/download?ref=fdaweb.com) entitled “Endosseous Dental Implants and Endosseous Dental Implant Abutments — Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for endosseous dental implants and endosseous dental implant abutments under CDRH’s Safety and Performance-Based Pathway. Under the framework, entities planning to submit a 510(k) using the pathway for endosseous dental implants and abutments will have the option to use the performance criteria proposed in the guidance to support substantial equivalence, rather than directly comparing the performance of the subject device to that of a predicate device, according to the agency.