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510(k) K241151

Device
LUXEN 5G
Applicant
Dentalmax Co., Ltd.
510(k) number
K241151
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-30
Date received
2024-04-25
Regulation
872.6660
Classification name
Powder, Porcelain
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Eunju Choi
Address
50-7, Pungsesandan 2-Ro Pungse-Myeon, Dongnam-Gu Cheonan-Si KR 31217 31217

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K252789Glass CeramicShenzhen Xiangtong Co., Ltd.2025-12-08
K252446BruxZir® NOWPrismatik Dentalcraft, Inc.2025-09-03
K251593DenMat Multilayered Zirconia DiscDenmat Holding, LLC2025-08-25