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FDA 510(k) Application Details - K052820
Device Classification Name
Material, Tooth Shade, Resin
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510(K) Number
K052820
Device Name
Material, Tooth Shade, Resin
Applicant
COLTENE/WHALEDENT AG
1349 LEXINGTON AVENUE
NEW YORK, NY 10128 US
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Contact
H. J. VOGELSTEIN
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
10/04/2005
Decision Date
01/09/2006
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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