
Dentsply Sirona
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Multibase Abutments EV and ATLANTIS Suprastructures is an FDA 510(k)-cleared medical device (K163350) 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 March 30, 2017. Regulation: 8.