
Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind
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MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC is an FDA 510(k)-cleared medical device (K983876) manufactured by Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind. 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 15, 1998. Regulation: 8.