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Ace Surgical Supply Co., Inc.
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ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE is an FDA 510(k)-cleared medical device (K051381) manufactured by Ace Surgical 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 July 14, 2005. Regulation: 8.