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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 K210373
Device Name Clear Aligners
Applicant
Shenzhen Yinuo Dental Technology Co.Ltd
Xinfeng Industry Park #11,101-301,Xintian Community,
Guanhu St., Longhua
Shenzhen,  CN 518000
Applicant Contact Mo Yuyum
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.218, Bldg. 2, Yike Intelligent Innovation Park,
# 232 Kezhu Rd., Huangpu, Guangzhou
Guangzhou,  CN 510000
Correspondent Contact Gamma Zhang
Regulation Number872.5470
Classification Product Code
NXC  
Date Received02/08/2021
Decision Date 08/27/2021
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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