FDA 510(k) Application Details - K192992

Device Classification Name Cement, Dental

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510(K) Number K192992
Device Name Cement, Dental
Applicant 3M Deutschland GMBH
ESPE Platz, Seefeld
Bavaria 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 10/25/2019
Decision Date 11/05/2019
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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