PIT AND FISSURE CHEMICAL CURING SEALANT

PIT AND FISSURE CHEMICAL CURING SEALANT is an FDA 510(k)-cleared medical device (K011822) manufactured by Rite-Dent Manufacturing 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 August 6, 2001. Regulation: 8.