Issue Date: September 2, 2026
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Dental
Status: Final
Dental Curing Lights – Premarket Notification (510(k)) Submissions
FDA is announcing the availability of a final guidance titled “Dental Curing Lights–Premarket Notification (510(k)) Submissions.” This guidance provides recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental curing lights. It supersedes the guidance “Dental Curing Lights–Premarket Notification [510(k)] Submissions” dated March 27, 2006. The recommendations are intended to promote consistency and facilitate efficient review of these submissions.
Download the Guidance Document
