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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 K250222
Device Name SDF Pro
Applicant
Belport Company, Inc., Gingi-Pak
4825 Calle Alto
Camarillo,  CA  93012
Applicant Contact Peng Jingtian
Correspondent
Belport Company, Inc., Gingi-Pak
4825 Calle Alto
Camarillo,  CA  93012
Correspondent Contact Peng Jingtian
Regulation Number872.3260
Classification Product Code
PHR  
Date Received01/27/2025
Decision Date 05/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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