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FDA 510(k)

Copra Supreme

K-Number: K233064 · 2024-09-18

ApplicantWhitepeaks Dental Solutions GmbH
Decision Date2024-09-18
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Copra Supreme is the device name listed in this FDA 510(k) record. The listed applicant is Whitepeaks Dental Solutions GmbH. It received FDA 510(k) clearance on 2024-09-18 under 510(k) number K233064. 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 Copra Supreme?

Copra Supreme is a medical device that received FDA 510(k) clearance on 2024-09-18. The listed applicant is Whitepeaks Dental Solutions GmbH. The 510(k) number is K233064.

When did Copra Supreme receive FDA 510(k) clearance?

Copra Supreme received FDA 510(k) clearance on 2024-09-18, under 510(k) number K233064.

Who is the listed applicant for Copra Supreme?

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

What is the FDA product code for Copra Supreme?

The FDA product code for Copra Supreme is EIH.

Other records listing Whitepeaks Dental Solutions 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.

K232952Copran ZriK233158Copra Smile, Copra Supreme Hyperion

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.

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.K253191DCMhotbond zirconDental Creativ Management GmbH

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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