TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT

TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT is an FDA 510(k)-cleared medical device (K950514) manufactured by 3M Unitek. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 6, 1995. Regulation: 8.