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510(k) K143667

GC KommonBase by Gc Orthodontics America, Inc. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2015
Date Received
December 23, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Device Class
Class II
Regulation Number
872.3750
Review Panel
DE
Submission Type

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