TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG

TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG is an FDA 510(k)-cleared medical device (K001786) manufactured by Sulzer Calcitek, 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 June 20, 2000. Regulation: 8.