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FDA 510(k)

COPRAN ZR/ORIGIN YZ

K-Number: K092496 · 2009-09-18

ApplicantWhite Peaks Dental Systems GmbH & Co. KG
Decision Date2009-09-18
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COPRAN ZR/ORIGIN YZ is the device name listed in this FDA 510(k) record. The listed applicant is White Peaks Dental Systems GmbH & Co. KG. It received FDA 510(k) clearance on 2009-09-18 under 510(k) number K092496. 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 COPRAN ZR/ORIGIN YZ?

COPRAN ZR/ORIGIN YZ is a medical device that received FDA 510(k) clearance on 2009-09-18. The listed applicant is White Peaks Dental Systems GmbH & Co. KG. The 510(k) number is K092496.

When did COPRAN ZR/ORIGIN YZ receive FDA 510(k) clearance?

COPRAN ZR/ORIGIN YZ received FDA 510(k) clearance on 2009-09-18, under 510(k) number K092496.

Who is the listed applicant for COPRAN ZR/ORIGIN YZ?

The FDA 510(k) record lists White Peaks Dental Systems GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COPRAN ZR/ORIGIN YZ?

The FDA product code for COPRAN ZR/ORIGIN YZ 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.

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Other records listing White Peaks Dental Systems GmbH & Co. KG 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.

K131664COPRA TEMP PMMA-DISKK123680COPRANCOLOR

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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