FDA 510(k) Application Details - K173318

Device Classification Name Material, Impression

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510(K) Number K173318
Device Name Material, Impression
Applicant 3M Deutschland GmbH
ESPE Platz
Seefeld 82229 DE
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Contact Ruediger Franke
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Regulation Number 872.3660

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Classification Product Code ELW
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Date Received 10/20/2017
Decision Date 10/31/2017
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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