STERNGOLD 1, MODEL 1127781

STERNGOLD 1, MODEL 1127781 is an FDA 510(k)-cleared medical device (K022252) manufactured by Sterngold. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 18, 2002. Regulation: 8.