
Neodent USA, Inc.
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NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM is an FDA 510(k)-cleared medical device (K133592) manufactured by Neodent USA, 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 August 21, 2014. Regulation: 8.