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FDA 510(k) Application Details - K062344
Device Classification Name
Sealant, Pit And Fissure, And Conditioner
More FDA Info for this Device
510(K) Number
K062344
Device Name
Sealant, Pit And Fissure, And Conditioner
Applicant
VOCO GMBH
ANTON-FLETTNER-STRASSE 1-3
CUXHAVEN D-27472 DE
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Contact
MICHAEL SUES
Other 510(k) Applications for this Contact
Regulation Number
872.3765
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Classification Product Code
EBC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/11/2006
Decision Date
10/02/2006
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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