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FDA 510(k)

IPS E.MAX PRESS MULTI

K-Number: K120134 · 2012-06-25

ApplicantIvoclar Vivadent, AG
Decision Date2012-06-25
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IPS E.MAX PRESS MULTI is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2012-06-25 under 510(k) number K120134. 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 PRESS MULTI?

IPS E.MAX PRESS MULTI is a medical device that received FDA 510(k) clearance on 2012-06-25. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K120134.

When did IPS E.MAX PRESS MULTI receive FDA 510(k) clearance?

IPS E.MAX PRESS MULTI received FDA 510(k) clearance on 2012-06-25, under 510(k) number K120134.

Who is the listed applicant for IPS E.MAX PRESS MULTI?

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

What is the FDA product code for IPS E.MAX PRESS MULTI?

The FDA product code for IPS E.MAX PRESS MULTI is EIH.

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Other records listing Ivoclar Vivadent, AG as applicant

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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.

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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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