ATLANTIS Abutment for HIOSSEN ET implant

ATLANTIS Abutment for HIOSSEN ET implant is an FDA 510(k)-cleared medical device (K160626) manufactured by Dentsply Sirona. 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 28, 2016. Regulation: 8.