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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®
Applicant
Tedequim Srl
Bv. Los Polacos 6136.
Córdoba,  AR X5147GGP
Applicant Contact Leonor Pasteris
Correspondent
Compliance4Devices
118 W Prive Cr.
118 W Prive Cr.,  FL  33445
Correspondent Contact Juan Tezak
Regulation Number872.3260
Classification Product Code
PHR  
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
Predetermined Change
Control Plan Authorized		 No
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