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Heraeus Kulzer,GmbH
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HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM is an FDA 510(k)-cleared medical device (K034049) manufactured by Heraeus Kulzer,GmbH. 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 29, 2004. Regulation: 8.