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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 K250826
Device Name Multi M Series
Applicant
Dmax Co., Ltd.
89, Hosan-Ro, Dalseo-Gu
Daegu,  KR 42710
Applicant Contact Priscilla Chung
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman, Suite 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/18/2025
Decision Date 06/12/2025
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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