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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K251775
Device Name RODIN Cement
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 Number872.3275
Classification Product Code
EMA  
Date Received06/10/2025
Decision Date 09/02/2025
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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