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510(k) K131376

SMARTCOAT 2.5% NAF VARNISH by Elevate Oral Care — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2013
Date Received
May 14, 2013
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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