3M Filtek Supreme Flowable Restorative

3M Filtek Supreme Flowable Restorative is an FDA 510(k)-cleared medical device (K221695) manufactured by 3M Company Espe Dental Products. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 2022. Regulation: 8.