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FDA 510(k) Application Details - K112044
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K112044
Device Name
Material, Tooth Shade, Resin
Applicant
ANAXDENT GMBH
14500 FIM 470
TARPLEY, TX 78883 US
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Contact
JOHN BALISTRERI
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
07/18/2011
Decision Date
01/26/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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