LEGACY3 6MM LENGTH IMPLANTS

LEGACY3 6MM LENGTH IMPLANTS is an FDA 510(k)-cleared medical device (K131097) manufactured by Implant Direct Sybron Manufacturing, LLC. 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, 2013. Regulation: 8.