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FDA 510(k) Application Details - K010196
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K010196
Device Name
Material, Tooth Shade, Resin
Applicant
BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG, IL 60193 US
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Contact
CYNDY ORIS
Other 510(k) Applications for this Contact
Regulation Number
872.3690
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Classification Product Code
EBF
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More FDA Info for this Product Code
Date Received
01/22/2001
Decision Date
04/05/2001
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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