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FDA 510(k)

INCORIS ZI

K-Number: K062509 · 2006-09-12

ApplicantSirona Dental Systems GmbH
Decision Date2006-09-12
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INCORIS ZI is the device name listed in this FDA 510(k) record. The listed applicant is Sirona Dental Systems GmbH. It received FDA 510(k) clearance on 2006-09-12 under 510(k) number K062509. 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 INCORIS ZI?

INCORIS ZI is a medical device that received FDA 510(k) clearance on 2006-09-12. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K062509.

When did INCORIS ZI receive FDA 510(k) clearance?

INCORIS ZI received FDA 510(k) clearance on 2006-09-12, under 510(k) number K062509.

Who is the listed applicant for INCORIS ZI?

The FDA 510(k) record lists Sirona Dental Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INCORIS ZI?

The FDA product code for INCORIS ZI is EIH.

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Other records listing Sirona Dental Systems GmbH 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.

K160099CEREC SpeedGlazeK132773SIDEXIS 4K123664INCORIS ZIK123952CEREC BLOCS C INK123070GALILEOS FAMILYK123545INCORIS TZI

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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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