PREMIER SELF-ETCHING ENAMEL SEALANT

PREMIER SELF-ETCHING ENAMEL SEALANT is an FDA 510(k)-cleared medical device (K061997) manufactured by Premier Dental Products 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 3, 2006. Regulation: 8.