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510(k) K172047

Riva Star by Sdi Limited — Product Code PHR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 11, 2018
Date Received: July 6, 2017
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.