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FDA 510(k) Application Details - K001799
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K001799
Device Name
Material, Tooth Shade, Resin
Applicant
AUSTENAL, INC.
4101 WEST 51ST ST.
CHICAGO, IL 60632-4287 US
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RONALD DUDEK
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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
06/14/2000
Decision Date
08/10/2000
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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