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

Issue Date: September 2, 2026
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Dental
Status: Final

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

FDA is announcing the availability of a final guidance titled “Dental Composite Resin Devices–Premarket Notification (510(k)) Submissions.” This guidance provides recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin devices. It supersedes the guidance “Dental Composite Resin Devices–Premarket Notification [510(k)] Submissions” dated October 26, 2005. The recommendations are intended to promote consistency and facilitate efficient review of these submissions.

Download the Guidance Document