XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM

XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM is an FDA 510(k)-cleared medical device (K024004) manufactured by Friadent 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 March 2, 2003. Regulation: 8.