NEODENT IMPLANT SYSTEM

NEODENT IMPLANT SYSTEM is an FDA 510(k)-cleared medical device (K101945) manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 25, 2011. Regulation: 8.