
Ivoclar USA, Inc.
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HIGH GOLD PALLADIUM FREE CERAMIC SOLDER is an FDA 510(k)-cleared medical device (K012877) manufactured by Ivoclar USA, 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 November 20, 2001. Regulation: 8.