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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K231793
Device Name RODIN 3D Resin SPLINT, Hard/Flex
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
Classification Product Code
MQC  
Subsequent Product Code
KMY  
Date Received06/20/2023
Decision Date 03/26/2024
Decision Substantially Equivalent (SESE)
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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