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510(k) K222323

Black Diamond by Elevate Oral Care, LLC — Product Code PHR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 23, 2023
Date Received: August 2, 2022
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.