
Sterngold/Implamed
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STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 is an FDA 510(k)-cleared medical device (K984340) manufactured by Sterngold/Implamed. 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 7, 1999. Regulation: 8.