FDA Replaces Two-Decade-Old Guidances for Composite Resin and Curing Light Submissions

Edited by Dentaltown staff

The Food and Drug Administration issued two final guidance documents Sept. 2 setting out what manufacturers should include in premarket notification submissions for dental composite resin devices and dental curing lights, replacing recommendations that had stood since 2005 and 2006.

Both documents cover device description, performance testing, and labeling for 510(k) submissions. The agency said the recommendations are meant to promote consistency and make review of those submissions more efficient.

The composite resin guidance supersedes a version dated Oct. 26, 2005. The curing light guidance supersedes one dated March 27, 2006. Draft versions of both appeared for comment in July 2024.

The FDA described the changes it made in response to those comments. For composite resin devices, the agency clarified what performance testing is appropriate for evaluating shelf life. For curing lights, it specified radiant power output measured at the tip rather than 2 millimeters from the tip, and removed resin depth-of-cure measurements.

The agency defines dental composite resin devices as devices intended to fill and restore defects or carious lesions, supplied either as a two-part self-cured base and catalyst system or a one-part system cured by photoinitiation. Dental curing lights are defined as devices emitting non-ionizing optical radiation intended to photopolymerize dental restorative resins.

The guidances were issued under the FDA’s good guidance practices regulation and represent the agency’s current thinking. They do not establish rights for any person and are not binding on the FDA or the public, and manufacturers may use an alternative approach that satisfies applicable statutes and regulations.

The notice of availability was published in the Federal Register under docket numbers FDA-2024-D-2511 for composite resin devices and FDA-2024-D-2512 for curing lights. Comments on agency guidances may be submitted at any time.

Sources:
Federal Register, “Dental Composite Resin Devices and Dental Curing Lights—Premarket Notification (510(k)) Submissions Guidances; Availability,” Sept. 2, 2026: federalregister.gov/documents/2026/09/02/2026-17933
U.S. Food and Drug Administration, CDRH New — News and Updates: fda.gov/medical-devices/cdrh-new-news-and-updates