
Bisco, Inc.
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BISCO DUO LINK D/C LUTING COMPOSITE is an FDA 510(k)-cleared medical device (K934596) 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 January 25, 1994. Regulation: 8.