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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 K251758
Device Name Serafin®
Applicant
Tns Co., Ltd.
19f, Unit 1907, Daeryung Post Tower 6th
298 Beotkkot-Ro, Geumcheon-Gu
Seoul,  KR 08510
Applicant Contact Byung Ju Kang
Correspondent
Tns Co., Ltd.
19f, Unit 1907, Daeryung Post Tower 6th
298 Beotkkot-Ro, Geumcheon-Gu
Seoul,  KR 08510
Correspondent Contact Byung Ju Kang
Regulation Number872.5470
Classification Product Code
NXC  
Date Received06/09/2025
Decision Date 09/11/2025
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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