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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 K231557
Device Name ZENEX FreeMilling & CCM Cast Abutment
Applicant
Izenimplant Co., Ltd.
1, 2Dong, 26-32, Suworam 4-Gil, Seotan-Myeon
Pyeongtaek-Si,  KR 17703
Applicant Contact Ji-Hwan Jeong
Correspondent
Withus Group Inc
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/30/2023
Decision Date 08/24/2023
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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