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Heraeus Kulzer, LLC
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PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID is an FDA 510(k)-cleared medical device (K110037) 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 April 28, 2011. Regulation: 8.