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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
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