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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K240688
Device Name RODIN Titan 3D Resin
Applicant
Belport Company, Inc., Gingi-Pak
670 Endeavor Circle
Brea,  CA  92821
Applicant Contact Daniel Gallegos
Correspondent
Belport Company, Inc., Gingi-Pak
670 Endeavor Circle
Brea,  CA  92821
Correspondent Contact Daniel Gallegos
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Code
EBF  
Date Received03/13/2024
Decision Date 06/20/2024
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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