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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 K243103
Device Name Denture Base
Applicant
Riton 3D Technology Co., Ltd.
Rm. C101, Bldg. 2, # 21, Hejing S. Rd.
Liwan District
Guangzhou,  CN 51038
Applicant Contact Zhou BinBin
Correspondent
Riton 3D Technology Co., Ltd.
Rm. C101, Bldg. 2, # 21, Hejing S. Rd.
Liwan District
Guangzhou,  CN 51038
Correspondent Contact Reanny Wang
Regulation Number872.3760
Classification Product Code
EBI  
Date Received09/30/2024
Decision Date 12/23/2024
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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