CreoDent Solidex Customized Abutment and Screw

CreoDent Solidex Customized Abutment and Screw is an FDA 510(k)-cleared medical device (K202095) manufactured by Creodent Prosthetics, Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2020. Regulation: 8.