BELLEGLASS HP ENAMEL REPAIR MATERIAL

BELLEGLASS HP ENAMEL REPAIR MATERIAL is an FDA 510(k)-cleared medical device (K971762) manufactured by Sybron Dental Specialties, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 11, 1997. Regulation: 8.