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FDA 510(k) Application Details - K152927
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K152927
Device Name
Material, Tooth Shade, Resin
Applicant
COLTENE/WHALEDENT AG
FELDWIESENTR. 20
ALTSTATTEN 9450 CH
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Contact
SILKE WALLASCHEK
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
10/05/2015
Decision Date
04/28/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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