FDA Issues Final Guidances for Dental Composite Resin Devices and Curing Lights

The U.S. Food and Drug Administration (FDA) has announced the availability of two final guidances for industry titled 'Dental Composite Resin Devices—Premarket Notification (510(k)) Submissions' and 'Dental Curing Lights—Premarket Notification (510(k)) Submissions.' These documents provide updated recommendations for device description, performance testing, and labeling to streamline the review process for these dental devices.