FDA 510(k) Application Details - K153174

Device Classification Name Cement, Dental

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510(K) Number K153174
Device Name Cement, Dental
Applicant 3M DEUTSCHLAND GMBH
ESPE PLATZ
SEEFELD 82229 DE
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Contact RUEDIGER FRANKE
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 11/03/2015
Decision Date 04/13/2016
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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