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FDA 510(k) Application Details - K994304
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K994304
Device Name
Material, Tooth Shade, Resin
Applicant
VOCO GMBH
7527 WESTMORELAND AVE.
ST. LOUIS, MO 63105 US
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Contact
EVAN DICK
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
12/21/1999
Decision Date
02/07/2000
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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