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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 K221969
Device Name IU Implant System Abutment
Applicant
Warantec Co., Ltd,
411~412, 474, Dunchon-dearo, Jungwon-gu
Seongnam-si,  KR 13229
Applicant Contact Younggwang Choi
Correspondent
Warantec Co., Ltd,
411~412, 474, Dunchon-dearo, Jungwon-gu
Seongnam-si,  KR 13229
Correspondent Contact Younggwang Choi
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/05/2022
Decision Date 05/12/2023
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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