The Food and Drug Administration (FDA or Agency) is announcing the availability of two final guidances titled "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. These guidances supersede the guidances "Dental Composite Resin Devices-- Premarket Notification [510(k)] Submissions" dated October 26, 2005 and "Dental Curing Lights--Premarket Notification [510(k)] Submissions" dated March 27, 2006. The recommendations in these guidances are intended to promote consistency and facilitate efficient review of these submissions.
US Federal Register - FDA Notices · September 02, 2026
Dental Composite Resin Devices and Dental Curing Lights—Premarket Notification (510(k)) Submissions Guidances
Original title: Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability
FDA issues final guidance on 510(k) submission requirements for dental composite resin devices and dental curing lights, superseding 2005 and 2006 guidances.
Published by US Federal Register - FDA Notices. HealthSignal links to the original document; the summary above is extracted from the source text.