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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 K221972
Device Name Warantec Custom 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 10/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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