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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 K172345
Device Name IU Implant System
Applicant
Warantec Co., Ltd.
#411, #412, 474, Dunchon-Daero, Jungwon-Gu
Seongnam-Si,  KR 13229
Applicant Contact Dong-Hwa Jang
Correspondent
Plusglobal
300, Atwood St.
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/02/2017
Decision Date 06/18/2018
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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