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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 K250823
Device Name Any-Com Flow
Applicant
Mediclus Co., Ltd.
# 1210, 134 Gongdan-Ro, Heungdeok-Gu
Cheongju-Si,  KR 28576
Applicant Contact Priscilla Chung
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman, Suite 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number872.3690
Classification Product Code
EBF  
Date Received03/18/2025
Decision Date 04/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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