
Degussa - Ney Dental, Inc.
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CERCON CERAM is an FDA 510(k)-cleared medical device (K011333) manufactured by Degussa - Ney Dental, 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 19, 2001. Regulation: 8.