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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 a medical device manufactured by Dentalmax Co., Ltd.. It received FDA 510(k) clearance on 2018-10-31 under approval 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. It is manufactured by Dentalmax Co., Ltd.. The 510(k) number is K171585.

When was LUXEN Zr, LUXEN Smile approved by the FDA?

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

What company makes LUXEN Zr, LUXEN Smile?

LUXEN Zr, LUXEN Smile is manufactured by Dentalmax Co., Ltd..

What is the FDA product code for LUXEN Zr, LUXEN Smile?

The FDA product code for LUXEN Zr, LUXEN Smile is EIH.

Other Devices by Dentalmax Co., Ltd.

K212548LUXEN CL Dental Liquid K241151LUXEN 5G

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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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