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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 K202418
Device Name Magic UCLA Abutment System
Applicant
InnoBioSurg Co., Ltd.
44-19, Techno 10-ro, Yuseong-gu
Daejeon,  KR 34027
Applicant Contact Sun-Mi Park
Correspondent
Withus Group Inc.
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/24/2020
Decision Date 12/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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