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FDA 510(k) Application Details - K072978
Device Classification Name
Adhesive, Bracket And Tooth Conditioner, Resin
More FDA Info for this Device
510(K) Number
K072978
Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Applicant
MICERIUM S.P.A.
VIA MARCONI 83
AVEGNO, GENOA 16030 IT
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Contact
EUGENIO MICELI
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Regulation Number
872.3750
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Classification Product Code
DYH
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More FDA Info for this Product Code
Date Received
10/22/2007
Decision Date
01/17/2008
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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