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FDA 510(k)

IPS e.max Zirconia

K-Number: K253953 · 2026-03-10

ApplicantIvoclar Vivadent, Inc.
Decision Date2026-03-10
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IPS e.max Zirconia is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2026-03-10 under 510(k) number K253953. 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 IPS e.max Zirconia?

IPS e.max Zirconia is a medical device that received FDA 510(k) clearance on 2026-03-10. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K253953.

When did IPS e.max Zirconia receive FDA 510(k) clearance?

IPS e.max Zirconia received FDA 510(k) clearance on 2026-03-10, under 510(k) number K253953.

Who is the listed applicant for IPS e.max Zirconia?

The FDA 510(k) record lists Ivoclar Vivadent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPS e.max Zirconia?

The FDA product code for IPS e.max Zirconia is EIH.

Related Clinical Trials

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.

NCT06898411Clinical Evaluation on the Longevity of Glass Ceramic Based Single Tooth RestorationsCOMPLETEDNCT07622043Effectiveness of Two Different Desensitizing Dental VarnishesNOT_YET_RECRUITING

Other records listing Ivoclar Vivadent, Inc. 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.

K261485Tetric plus Fill;Tetric plus FlowK252450Adhese 2K233995Ivotion Base PrintK210804Adhese Universal DC, Cention PrimerK211916IPS e.max OneK193193Telio CAD Abutment Solutions- extra systems

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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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