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FDA 510(k) Application Details - K143667
Device Classification Name
Adhesive, Bracket And Tooth Conditioner, Resin
More FDA Info for this Device
510(K) Number
K143667
Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Applicant
GC Orthodontics America Inc.
11535 S.Central Avenue
Alsip, IL 60803 US
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Contact
Tom Macari
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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
12/23/2014
Decision Date
05/07/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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