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FDA 510(k) Application Details - K033703
Device Classification Name
Adhesive, Bracket And Tooth Conditioner, Resin
More FDA Info for this Device
510(K) Number
K033703
Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Applicant
DENTSPLY INTL.
570 WEST COLLEGE AVENUE
P.O. BOX 872
YORK, PA 17405-0872 US
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Contact
P. JEFFERY LEHN
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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
11/25/2003
Decision Date
02/06/2004
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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