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FDA 510(k) Application Details - K143104
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K143104
Device Name
Material, Tooth Shade, Resin
Applicant
KETTENBACH GMBH & CO KG
IM HEERFELD 7
ESCHENBURG D-35713 DE
Other 510(k) Applications for this Company
Contact
Katja Simon
Other 510(k) Applications for this Contact
Regulation Number
872.3690
More FDA Info for this Regulation Number
Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/29/2014
Decision Date
03/25/2015
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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