FDA 510(k) Application Details - K111185

Device Classification Name Cement, Dental

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510(K) Number K111185
Device Name Cement, Dental
Applicant 3M ESPE DENTAL PRODUCTS
3M CENTER, BUILDING 260-2A-11
ST. PAUL, MN 55144-1000 US
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Contact BERNARDO MEDELLIN, J.D.
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 04/27/2011
Decision Date 05/05/2011
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 Y
Expedited Review



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