3I T3(R) EXTERNAL HEX DENTAL IMPLANTS

3I T3(R) EXTERNAL HEX DENTAL IMPLANTS is an FDA 510(k)-cleared medical device (K133049) manufactured by Biomet 3i. 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 7, 2014. Regulation: 8.