ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN

ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN is an FDA 510(k)-cleared medical device (K921283) manufactured by Jeneric/Pentron, 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 22, 1992. Regulation: 8.