JUMBO SILVER-REINFORCED GLASS IONOMER

JUMBO SILVER-REINFORCED GLASS IONOMER is an FDA 510(k)-cleared medical device (K982665) manufactured by Centrix, 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 7, 1998. Regulation: 8.