SMARTbase Abutment System

SMARTbase Abutment System is an FDA 510(k)-cleared medical device (K223535) 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 June 19, 2023. Regulation: 8.