DYRACT SEAL COMPOMER PIT & FISSURE SEALANT

DYRACT SEAL COMPOMER PIT & FISSURE SEALANT is an FDA 510(k)-cleared medical device (K992516) manufactured by Dentsply 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 August 26, 1999. Regulation: 8.