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FDA 510(k) Application Details - K143656
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K143656
Device Name
Powder, Porcelain
Applicant
H.C. Starck Ceramics GmbH
Lorenz-Hutschenreuther-Str. 81
Selb 95100 DE
Other 510(k) Applications for this Company
Contact
Alexandra Krausch
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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