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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 K223517
Device Name Clear Aligner
Applicant
Wuxi EA Medical Instruments Technologies Limited.
No.1619 Huishan Avenue, Huishan Economic Development Zone
Wuxi,  CN
Applicant Contact Jessica Luo
Correspondent
Prime Path Medtech
1321 Upland Dr. Suite 6792
Houston,  TX  77043
Correspondent Contact Breanne Butler
Regulation Number872.5470
Classification Product Code
NXC  
Date Received11/23/2022
Decision Date 06/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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