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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K230465
Device Name Hi-Bond Universal
Applicant
Mediclus Co., Ltd.
# 1210, 134 Gongdan-Ro, Heungdeok-Gu
Cheongju-Si,  KR
Applicant Contact Hyeon-A Jo
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman Ave.
Suite 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Codes
EBF   LBH  
Date Received02/21/2023
Decision Date 05/22/2023
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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