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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name diammine silver fluoride dental hypersensitivity varnish
510(k) Number K240059
Device Name FAgamin®
Tedequim SRL
Bv. Los Polacos 6136.
Córdoba,  AR X5147GGP
Applicant Contact Leonor Pasteris
Compliance 4 Devices
118 W Prive Cr.
Delray Beach,  FL  33445
Correspondent Contact Juan Tezak
Regulation Number872.3260
Classification Product Code
Date Received01/08/2024
Decision Date 05/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No