Home / 510(k) Clearances / K240059

510(k) K240059

FAgamin® by Tedequim Srl — Product Code PHR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 16, 2024
Date Received: January 8, 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.