CHEMICAL CURE COMPOSITE WITH ENAMEL BOND

CHEMICAL CURE COMPOSITE WITH ENAMEL BOND is an FDA 510(k)-cleared medical device (K982191) manufactured by Medental Intl.. 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 13, 1998. Regulation: 8.