RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT

RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT is an FDA 510(k)-cleared medical device (K042215) manufactured by Premier Dental Products Co.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 20, 2004. Regulation: 8.