
Sterngold/Implamed
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STERNGOLD BIO-5 (1127210) is an FDA 510(k)-cleared medical device (K962326) 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 July 23, 1996. Regulation: 8.