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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K251415
Device Name Additively Manufactured Aligner Resin
Applicant
Aidite (Qinhuangdao) Technology Co., Ltd.
#9 Dushan Rd.
Economic And Technological Development Zone
Qinhuangdao,  CN 066004
Applicant Contact Zhanfu Ye
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number872.5470
Classification Product Code
NXC  
Subsequent Product Code
MQC  
Date Received05/07/2025
Decision Date 08/27/2025
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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