
Degussa - Ney Dental, Inc.
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CERGOGOLD is an FDA 510(k)-cleared medical device (K993897) 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 January 9, 2000. Regulation: 8.