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Mycone Dental Supply Co., Inc.
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SEITY 37% PHOSPHORIC ACID ETCHANT GEL is an FDA 510(k)-cleared medical device (K112597) manufactured by Mycone Dental Supply Co., 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 6, 2011. Regulation: 8.