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Hans Biomed Corp.
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SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY is an FDA 510(k)-cleared medical device (K130235) manufactured by Hans Biomed Corp.. 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 9, 2014. Regulation: 8.