
American Green Dent. Mfg, Inc.
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DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST is an FDA 510(k)-cleared medical device (K033045) manufactured by American Green Dent. Mfg, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 22, 2003. Regulation: 8.