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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K232170
Device Name Ti Link Abutment
Applicant
Izenimplant Co., Ltd.
1, 2dong, 26-32, Suworam 4-Gil, Seotan-Myeon
Pyeongtaek-Si,  KR 17703
Applicant Contact Mi-Kyung Kwon
Correspondent
Withus Group, Inc.
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/21/2023
Decision Date 01/12/2024
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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