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510(k) K153334

Oral-B 5% Sodium Fluoride Varnish by Young Dental Manufacturing Co. 1, LLC — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2016
Date Received
November 19, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type

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