FDA 510(k) Application Details - K060881

Device Classification Name Crown And Bridge, Temporary, Resin

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510(K) Number K060881
Device Name Crown And Bridge, Temporary, Resin
Applicant COSMEDENT, INC.
401 NORTH MICHIGAN AVE.
SUITE 2500
CHICAGO, IL 60611 US
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Contact JAMES L SANDRIK
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Regulation Number 872.3770

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Classification Product Code EBG
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Date Received 03/31/2006
Decision Date 05/16/2006
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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