NEODENT IMPLANT SYSTEM

NEODENT IMPLANT SYSTEM is an FDA 510(k)-cleared medical device (K133510) manufactured by Jj Industria E Comercio DE Materiais Dentarios SA. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 23, 2014. Regulation: 8.