FDA 510(k) Application Details - K143656

Device Classification Name Powder, Porcelain

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510(K) Number K143656
Device Name Powder, Porcelain
Applicant H.C. Starck Ceramics GmbH
Lorenz-Hutschenreuther-Str. 81
Selb 95100 DE
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Contact Alexandra Krausch
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 12/23/2014
Decision Date 07/09/2015
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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