FDA 510(k)

LUXEN 5G

K-Number: K241151 · 2024-09-30

Decision Date2024-09-30

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

LUXEN 5G is the device name listed in this FDA 510(k) record. The listed applicant is Dentalmax Co., Ltd.. It received FDA 510(k) clearance on 2024-09-30 under 510(k) number K241151. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUXEN 5G?

LUXEN 5G is a medical device that received FDA 510(k) clearance on 2024-09-30. The listed applicant is Dentalmax Co., Ltd.. The 510(k) number is K241151.

When did LUXEN 5G receive FDA 510(k) clearance?

LUXEN 5G received FDA 510(k) clearance on 2024-09-30, under 510(k) number K241151.

Who is the listed applicant for LUXEN 5G?

The FDA 510(k) record lists Dentalmax Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUXEN 5G?

The FDA product code for LUXEN 5G is EIH.

Other records listing Dentalmax Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212548LUXEN CL Dental Liquid K171585LUXEN Zr, LUXEN Smile

Related Devices (Code: EIH)

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba Dandy K260918Zolid LunarisAmann Girrbach AG K260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.