AURAVUE PIT & FISSURE SEALANT

AURAVUE PIT & FISSURE SEALANT is an FDA 510(k)-cleared medical device (K070693) manufactured by Denali Corporation. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 8, 2007. Regulation: 8.