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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 a medical device manufactured by Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2026-03-10 under approval 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. It is manufactured by Ivoclar Vivadent, Inc.. The 510(k) number is K253953.

When was IPS e.max Zirconia approved by the FDA?

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

What company makes IPS e.max Zirconia?

IPS e.max Zirconia is manufactured by Ivoclar Vivadent, Inc..

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

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

Other Devices by Ivoclar Vivadent, Inc.

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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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