FDA 510(k) Application Details - K110508

Device Classification Name Cement, Dental

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510(K) Number K110508
Device Name Cement, Dental
Applicant 3M ESPE AG
ESPE PLATZ
SEEFELD, BAVARIA D-82229 DE
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Contact DESI W SOEGIARTO
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 02/22/2011
Decision Date 06/03/2011
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 N
Expedited Review



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