IONOSIT BOND

IONOSIT BOND is an FDA 510(k)-cleared medical device (K991172) manufactured by Dmg Chemisch Pharmazeutische Fabrik GmbH. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 16, 1999. Regulation: 8.