FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DENTAL COMPOSITE RESIN DEVICES AND DENTAL CURING LIGHTS-PREMARKET NOTIFICATION (510(K)) SUBMISSIONS GUIDANCES; GUIDANCES FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF; AVAILABILITY

WASHINGTON, Sept. 2 -- Food and Drug Administration has issued a notice called: Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability.

The notice was published in the Federal Register on Sept. 2 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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 ...