This guidance document provides the FDA’s recommendations on performance criteria to support premarket submissions for endosseous dental implants and abutments in the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for endosseous dental implants and abutments will have the option to use the performance criteria proposed in this final guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. The recommendations are intended to promote consistency and facilitate efficient review of endosseous dental implants and abutments.
Endosseous Dental Implants and Abutments Performance Criteria
This guidance provides performance criteria for endosseous dental implants and abutments in support of the Safety and Performance Based Pathway.
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