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FDA 510(k) Application Details - K172707
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K172707
Device Name
Material, Tooth Shade, Resin
Applicant
Cosmedent, Inc
401 N. Michigan Ave, Suite 2500
Chicago, IL 60611 US
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Contact
Mary Nowak
Other 510(k) Applications for this Contact
Regulation Number
872.3690
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Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/08/2017
Decision Date
12/05/2017
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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