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# Two Guidances on Dental Composites and Curing Lights
- URL: https://www.fdaweb.com/two-guidances-on-dental-composites-and-curing-lights/
- Published: 2026-09-01T12:00:00.000Z
- Updated: 2026-09-14T12:05:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161717

FDA has released two guidance documents on dental-related medical devices.

The [one guidance](https://www.fda.gov/media/74206/download?ref=fdaweb.com), *Dental Curing Lights – Premarket Notification (510(k)) Submissions*, provides recommendations for 510(k) submissions for dental curing lights that emit non-ionizing optical radiation intended to photopolymerize dental restorative resins. FDA is issuing this guidance to clarify and provide recommendations for premarket submissions for such devices. It includes references to relevant consensus standards.

The [other guidance](https://www.fda.gov/media/71305/download?ref=fdaweb.com), *Dental Composite Resin Devices – Premarket Notification (510(k)) Submissions*, provides recommendations for 510(k) submissions for dental composite resins used in dentistry, which are intended to fill and restore defects or carious lesions in teeth. It says such devices can be supplied as a two-part base and catalyst system that is self-cured or a one-part system that is cured via photoinitiation. The document does not cover resin restoratives intended for other uses, such as cementing, coating, fixation, and temporary restoration, the agency says.