Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants is an FDA 510(k)-cleared medical device (K251205) 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 November 20, 2025. Regulation: 8.