
Creodent Prosthetics, Ltd.
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CREOKORREKT Aligners is an FDA 510(k)-cleared medical device (K211427) 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 October 12, 2022. Regulation: 8.