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GUIDANCE DOCUMENT

Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration Staff October 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2024-D-4409
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-4409.

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