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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K203672
Device Name MAZIC Claro CAD and MAZIC Claro Press
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 Number872.6660
Classification Product Code
EIH  
Date Received12/16/2020
Decision Date 07/01/2021
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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