OPTIBOND 2A PRECOAT

OPTIBOND 2A PRECOAT is an FDA 510(k)-cleared medical device (K955068) 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 December 10, 1995. Regulation: 8.