CONCEPT HP ADD-ON; CONCEPT HP ENAMEL

CONCEPT HP ADD-ON; CONCEPT HP ENAMEL is an FDA 510(k)-cleared medical device (K033773) manufactured by Ivoclar Vivadent, AG. 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 14, 2004. Regulation: 8.