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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
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