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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 K200753
Device Name IBS Implant System II
InnoBioSurg Co., Ltd.
44-19, Techno 10-ro, Yuseong-gu
Daejeon,  KR 34027
Applicant Contact Bo-Yeon Lim
Withus Group, Inc.
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.3630
Classification Product Code
Date Received03/23/2020
Decision Date 06/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No