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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K260419
Device Name LingOral Dental Design System
Applicant
Hangzhou ChohoTech Co., Ltd.
Rm. 405, F4, Bldg. 5, # 188, Lianchuang St.
Yuhang District
Hangzhou,  CN 311100
Applicant Contact Cui Jianqiao Cui
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Ariel Xiang
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
NOF  
Date Received02/09/2026
Decision Date 05/08/2026
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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