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510(k) K231338

3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment by 3M Espe Dental Products — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2023
Date Received
May 8, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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