AURAFILL* DENTAL RESTORATIVE

AURAFILL* DENTAL RESTORATIVE is an FDA 510(k)-cleared medical device (K822450) manufactured by Johnson & Johnson Professionals, Inc.. 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 13, 1982. Regulation: 8.