On September 1, 2026, the Food and Drug Administration (FDA) announced the availability of two final guidance entitled, Dental Composite Resin Devices--Premarket Notification (510(k)) Submissions and Dental Curing Lights--Premarket Notification (510(k)) Submissions. These guidance documents provide recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin devices and dental curing lights. The recommendations in this guidance are intended to promote consistency and facilitate efficient review of these submissions. This final guidance supersedes previous guidance issued in October 2005 and March 2006. 

The notice of the final guidance availability, as published in the Federal Register, may be found here.

Impact on General Dentistry: FDA finalized updated guidance for dental composite resin devices and dental curing lights used in routine restorative care. While the guidance does not impose new requirements on dental practices, it may improve consistency in the review and labeling of dental products, helping ensure that general dentists have access to safe and effective restorative materials and technologies.