FDA 510(k) Application Details - K171876

Device Classification Name Powder, Porcelain

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510(K) Number K171876
Device Name Powder, Porcelain
Applicant Amann Girrbach AG
Herrschaftswiesen 1
Koblach 6842 AT
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Contact Debora Engel
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 06/23/2017
Decision Date 09/20/2017
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 N
Expedited Review



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