Dental Cements – Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

Issue Date: September 30, 2024
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Dental
Status: Final

Dental Cements – Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

This guidance document provides the FDA’s recommendations on performance criteria to support premarket submissions for dental cements 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 dental cements 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 dental cements.

Download the Guidance Document