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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 K233544
Device Name MESHEET
Applicant
Dentis Co., Ltd
99, Seongseoseo-ro, Dalseo-gu
Daegu,  KR 42718
Applicant Contact Gyu Ri Kim
Correspondent
Dentis Co., Ltd
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.5470
Classification Product Code
NXC  
Date Received11/03/2023
Decision Date 02/22/2024
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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