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Bisco, Inc.
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BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 is an FDA 510(k)-cleared medical device (K082449) manufactured by Bisco, 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 September 24, 2008. Regulation: 8.