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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, Root-Form
510(k) Number K252585
Device Name ZENEX Implant System_R-System
Applicant
Izenimplant Co., Ltd.
1, 2dong, 26-32, Suworam 4-Gil, Seotan-Myeon
Pyeongtaek-Si,  KR 17703
Applicant Contact Kim Nayoung
Correspondent
Withus Group, Inc.
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/15/2025
Decision Date 01/08/2026
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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