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FDA 510(k) Application Details - K140976
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K140976
Device Name
Material, Tooth Shade, Resin
Applicant
KM CORPORATION
2651 E CHAPMAN AVE
STE 110
FULLERTON, CA 92831 US
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Contact
Priscilla Chung
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
04/16/2014
Decision Date
07/10/2014
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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