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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K193260
Device Name U-Cem Premium & MAZIC Cem
Applicant
Vericom Co., Ltd.
48, Toegyegongdan 1-Gil,
Chuncheon-Si,  KR 200-944
Applicant Contact Yun Ki Kim
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.3275
Classification Product Code
EMA  
Date Received11/26/2019
Decision Date 08/21/2020
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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