Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions

Guidance for Industry and Food and Drug Administration Staff

September 2026

FINAL Guidance Document: https://www.fda.gov/media/71305/download

Docket Number:

FDA-2024-D-2511

Issued by:

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.

Federal Register Notice: https://www.federalregister.gov/documents/2026/09/02/2026-17933/dental-composite-resin-devices-and-dental-curing-lights-premarket-notification-510k-submissions

Submit Comments

You can submit online https://www.regulations.gov/docket/FDA-2024-D-2511/document 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.

Dental Curing Lights - Premarket Notification (510(k)) Submissions

Guidance for Industry and Food and Drug Administration Staff

September 2026

FINAL Guidance Document: https://www.fda.gov/media/74206/download

Docket Number:

FDA-2024-D-2512

Issued by:

Center for Devices and Radiological Health

This guidance document provides the FDA’s recommendations on device description, performance testing, and labeling to support premarket submissions for dental curing light devices.  The recommendations are intended to promote consistency and facilitate efficient review of dental curing light submissions.

Federal Register Notice: https://www.federalregister.gov/documents/2026/09/02/2026-17933/dental-composite-resin-devices-and-dental-curing-lights-premarket-notification-510k-submissions

Submit Comments

You can submit online https://www.regulations.gov/docket/FDA-2024-D-2512/document 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-2512.