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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 K203688
Device Name Clear Aligner
Applicant
Wuxi EA Medical Instruments Technologies Limited.
# 1619, Huishan Ave., Huishan Economic Development Zone
Wuxi,  CN 214174
Applicant Contact Yan He
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number872.5470
Classification Product Code
NXC  
Date Received12/17/2020
Decision Date 10/08/2021
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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