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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 K241151
Device Name LUXEN 5G
Applicant
Dentalmax Co., Ltd.
50-7, Pungsesandan 2-Ro
Pungse-Myeon, Dongnam-Gu
Cheonan-Si,  KR 31217
Applicant Contact Eunju Choi
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman Ave. Suite 160
`
Irvine,  AR  92612
Correspondent Contact Priscilla Chung
Regulation Number872.6660
Classification Product Code
EIH  
Date Received04/25/2024
Decision Date 09/30/2024
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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