FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE

FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE is an FDA 510(k)-cleared medical device (K083610) manufactured by 3M Company. 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 16, 2008. Regulation: 8.