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FDA 510(k)

IPS E.MAX CAD/IPS E.MAX ZIRCAD

K-Number: K051705 · 2005-10-14

ApplicantIvoclar Vivadent, Inc.
Decision Date2005-10-14
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IPS E.MAX CAD/IPS E.MAX ZIRCAD 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 2005-10-14 under 510(k) number K051705. 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 CAD/IPS E.MAX ZIRCAD?

IPS E.MAX CAD/IPS E.MAX ZIRCAD is a medical device that received FDA 510(k) clearance on 2005-10-14. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K051705.

When did IPS E.MAX CAD/IPS E.MAX ZIRCAD receive FDA 510(k) clearance?

IPS E.MAX CAD/IPS E.MAX ZIRCAD received FDA 510(k) clearance on 2005-10-14, under 510(k) number K051705.

Who is the listed applicant for IPS E.MAX CAD/IPS E.MAX ZIRCAD?

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 CAD/IPS E.MAX ZIRCAD?

The FDA product code for IPS E.MAX CAD/IPS E.MAX ZIRCAD is EIH.

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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.

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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.

K262074Any-ZircosMediclus Co., Ltd.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.

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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