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510(k) K241041

Silver Fluoride Hypersensitivity Varnish by Young Dental Manufacturing Co. 1, LLC — Product Code PHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2025
Date Received
April 16, 2024
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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