Atlantis® Abutments in Titanium

Atlantis® Abutments in Titanium is an FDA 510(k)-cleared medical device (K250081) 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 April 10, 2025. Regulation: 8.