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GUIDANCE DOCUMENT

Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff  September 2026

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2024-D-2511
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document provides the FDA’s recommendations on device description, non-clinical performance testing, clinical performance testing and labeling to support premarket submissions for dental composite resin devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of dental composite resin submissions. 

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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-2511.

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