COMMAND ULTRASEAL PIT & FISSURE SEALANT

COMMAND ULTRASEAL PIT & FISSURE SEALANT is an FDA 510(k)-cleared medical device (K843024) manufactured by Kerr Corporation (Danbury). 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 26, 1984. Regulation: 8.