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FDA 510(k)

Soreal Press, Soreal CAD

K-Number: K230259 · 2023-05-25

ApplicantShenzhen Up3D Technology Co., Ltd.
Decision Date2023-05-25
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Soreal Press, Soreal CAD is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Up3D Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K230259. 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 Soreal Press, Soreal CAD?

Soreal Press, Soreal CAD is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Shenzhen Up3D Technology Co., Ltd.. The 510(k) number is K230259.

When did Soreal Press, Soreal CAD receive FDA 510(k) clearance?

Soreal Press, Soreal CAD received FDA 510(k) clearance on 2023-05-25, under 510(k) number K230259.

Who is the listed applicant for Soreal Press, Soreal CAD?

The FDA 510(k) record lists Shenzhen Up3D Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Soreal Press, Soreal CAD?

The FDA product code for Soreal Press, Soreal CAD is EIH.

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

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

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