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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 K213026
Device Name Clear Aligner
Applicant
Shenzhen Meiming Dentistry Technology Co., Ltd.
Floor 3, Buliding D, Fuxinlin Industrial Park, Mati Pond,
Gushu Community, Xixiang St., Baoan Dis
Shenzhen,  CN 518102
Applicant Contact Fei Hu
Correspondent
Shenzhen Meiming Dentistry Technology Co., Ltd.
Floor 3, Buliding D, Fuxinlin Industrial Park, Mati Pond,
Gushu Community, Xixiang St., Baoan Dis
Shenzhen,  CN 518102
Correspondent Contact Fei Hu
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/21/2021
Decision Date 08/16/2022
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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