ALPHA-DENT PIT AND FISSURE SEALANT

ALPHA-DENT PIT AND FISSURE SEALANT is an FDA 510(k)-cleared medical device (K924635) manufactured by Wallace A. Erickson & Co.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 15, 1992. Regulation: 8.