HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE

HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE is an FDA 510(k)-cleared medical device (K945451) manufactured by Shofu Dental Corp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 26, 1995. Regulation: 8.