DMRC Self-Cure Bracket Adhesive One Step and Primer

DMRC Self-Cure Bracket Adhesive One Step and Primer is an FDA 510(k)-cleared medical device (K142886) manufactured by Danville Materials, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 17, 2015. Regulation: 8.