
Heraeus Kulzer, LLC
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XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML is an FDA 510(k)-cleared medical device (K130647) manufactured by Heraeus Kulzer, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 16, 2013. Regulation: 8.