XIVE 3.0 DENTAL IMPLANT SYSTEM

XIVE 3.0 DENTAL IMPLANT SYSTEM is an FDA 510(k)-cleared medical device (K030639) manufactured by Friandent 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 August 11, 2003. Regulation: 8.