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FDA 510(k) Application Details - K102351
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K102351
Device Name
Material, Tooth Shade, Resin
Applicant
VOCO GMBH
ANTON-FLETTNER-STRASSE 1-3
CUXHAVEN D-27472 DE
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Contact
MANFIELD T PLAUMANN
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
08/19/2010
Decision Date
11/02/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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