OPC LOWWEAR PORCELAIN

OPC LOWWEAR PORCELAIN is an FDA 510(k)-cleared medical device (K982377) 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 August 17, 1998. Regulation: 8.