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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 K253334
Device Name ZENEX Implant System_Short (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  
Date Received09/30/2025
Decision Date 03/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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