FDA 510(k) Application Details - K073263

Device Classification Name Crown And Bridge, Temporary, Resin

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510(K) Number K073263
Device Name Crown And Bridge, Temporary, Resin
Applicant BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG, IL 60193 US
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Contact BENJAMIN LICHTENWALNER
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Regulation Number 872.3770

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Classification Product Code EBG
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Date Received 11/20/2007
Decision Date 02/14/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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