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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K260805
Device Name Dual Core
Applicant
Vericom Co., Ltd.
48,Toegyegongdan 1-Gil
Chuncheon-Si,  KR 24427
Applicant Contact Yun Ki Kim
Correspondent
LK Consulting Group USA, Inc.
2552 Wanut Ave. Suite 230
Tustin,  CA  92780
Correspondent Contact Priscilla Chung
Regulation Number872.3690
Classification Product Code
EBF  
Date Received03/12/2026
Decision Date 05/11/2026
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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