CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE

CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE is an FDA 510(k)-cleared medical device (K052097) manufactured by Dentsply International. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 2005. Regulation: 8.