ENAMELITE ACRYSEAL SPRAY SEALANT

ENAMELITE ACRYSEAL SPRAY SEALANT is an FDA 510(k)-cleared medical device (K093019) manufactured by Enamelite, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2009. Regulation: 8.