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3M Unitek
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TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE is an FDA 510(k)-cleared medical device (K100536) manufactured by 3M Unitek. 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 26, 2010. Regulation: 8.