PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT

PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT is an FDA 510(k)-cleared medical device (K945378) manufactured by Pulpdent Corp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 1995. Regulation: 8.