CreoDent Solidex Custom Abutment

CreoDent Solidex Custom Abutment is an FDA 510(k)-cleared medical device (K160436) 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 September 28, 2016. Regulation: 8.