OsseOne Dental Implant System

OsseOne Dental Implant System is an FDA 510(k)-cleared medical device (K182293) manufactured by Synoross Dba Osseone. 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 14, 2019. Regulation: 8.