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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Orthodontic
510(k) Number K231913
Device Name T-FIT
Applicant
Techwin Co., Ltd.
#401, Eungyenam-Gil 40
Siheung-Si,  KR 14922
Applicant Contact Min-jae Jo
Correspondent
Smb Korea
#606, #607, 7, Boramae-Ro 5ga-Gil, Donjak-Gu
Seoul,  KR 07071
Correspondent Contact Kyung-hwan Kim
Regulation Number872.3640
Classification Product Code
OAT  
Date Received06/29/2023
Decision Date 02/08/2024
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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