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510(k) K210115

FiteBac CC OrthoSeal by Largent Health, LLC — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2021
Date Received
January 19, 2021
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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