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FDA 510(k)

LUXEN Zr, LUXEN Smile

K-Number: K171585 · 2018-10-31

ApplicantDentalmax Co., Ltd.
Decision Date2018-10-31
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUXEN Zr, LUXEN Smile 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 2018-10-31 under 510(k) number K171585. 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 Zr, LUXEN Smile?

LUXEN Zr, LUXEN Smile is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Dentalmax Co., Ltd.. The 510(k) number is K171585.

When did LUXEN Zr, LUXEN Smile receive FDA 510(k) clearance?

LUXEN Zr, LUXEN Smile received FDA 510(k) clearance on 2018-10-31, under 510(k) number K171585.

Who is the listed applicant for LUXEN Zr, LUXEN Smile?

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 Zr, LUXEN Smile?

The FDA product code for LUXEN Zr, LUXEN Smile 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.

K241151LUXEN 5GK212548LUXEN CL Dental Liquid

Related Devices (Code: EIH)

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.

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

Official Source

View on FDA Database →

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

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