InterActive SMARTBase Abutments

InterActive SMARTBase Abutments is an FDA 510(k)-cleared medical device (K181359) 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 14, 2018. Regulation: 8.