https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-composite-resin-devices-premarket-notification-510k-submissions
Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions | FDA
This draft guidance provides recommendations to support a 510(k) submission for dental composite resin devices.
dental composite resinpremarket notificationdevices510submissions