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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K231060
Device Name ProMin Dental Desensitizing Gel
Applicant
Belport Company, Inc., Gingi-Pak
4825 Calle Alto
Camarillo,  CA  93012
Applicant Contact Jingtian Peng
Correspondent
Belport Company, Inc., Gingi-Pak
4825 Calle Alto
Camarillo,  CA  93012
Correspondent Contact Jingtian Peng
Regulation Number872.3260
Classification Product Code
LBH  
Subsequent Product Code
EJR  
Date Received04/13/2023
Decision Date 06/13/2024
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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