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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
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