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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 K232074
Device Name Serafin®
Applicant
Tns Co., Ltd.
908, 46, Digital-Ro 9gil
Geumcheon-Gu,  KR 08512
Applicant Contact Won-gun Chang
Correspondent
Tns Co., Ltd.
908, 46, Digital-Ro 9gil
Geumcheon-Gu,  KR 08512
Correspondent Contact Won-gun Chang
Regulation Number872.5470
Classification Product Code
NXC  
Date Received07/12/2023
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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