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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 K230009
Device Name EZ Bond Universal
Applicant
Meta Biomed Co., Ltd.
270, Osongsaengmyeong 1-Ro, Osong-Eup, Heungdeok-Gu
Cheongju-Si,  KR 28161
Applicant Contact Suk Song Oh
Correspondent
Withus Group, Inc.
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.3200
Classification Product Code
KLE  
Date Received01/03/2023
Decision Date 03/03/2023
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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