DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT

DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT is an FDA 510(k)-cleared medical device (K032195) manufactured by Dentaurum. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 6, 2003. Regulation: 8.