OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS

OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS is an FDA 510(k)-cleared medical device (K994435) manufactured by Jeneric/Pentron, 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 February 9, 2000. Regulation: 8.