EKO — Denture Preformed (Partially Prefabricated Denture) Class II

FDA Device Classification

FDA product code EKO covers "Denture Preformed (Partially Prefabricated Denture)", a Class II medical device regulated under 21 CFR 872.3600. Submissions are reviewed by the Dental panel. At least 4 recent 510(k) clearances have been granted under this product code.