Straumann Screw-Retained Abutments

Straumann Screw-Retained Abutments is an FDA 510(k)-cleared medical device (K192401) manufactured by Straumann USA, 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 April 5, 2020. Regulation: 8.