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510(k) K250222

SDF Pro by Belport Company, Inc., Gingi-Pak — Product Code PHR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 7, 2025
Date Received: January 27, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Diammine Silver Fluoride Dental Hypersensitivity Varnish
Device Class: Class II
Regulation Number: 872.3260
Review Panel: DE
Submission Type

Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.

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