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FDA 510(k)

Copra Smile, Copra Supreme Hyperion

K-Number: K233158 · 2024-06-20

ApplicantWhitepeaks Dental Solutions GmbH
Decision Date2024-06-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Copra Smile, Copra Supreme Hyperion 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 2024-06-20 under 510(k) number K233158. 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 Smile, Copra Supreme Hyperion?

Copra Smile, Copra Supreme Hyperion is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Whitepeaks Dental Solutions GmbH. The 510(k) number is K233158.

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

Copra Smile, Copra Supreme Hyperion received FDA 510(k) clearance on 2024-06-20, under 510(k) number K233158.

Who is the listed applicant for Copra Smile, Copra Supreme Hyperion?

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 Smile, Copra Supreme Hyperion?

The FDA product code for Copra Smile, Copra Supreme Hyperion 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.

K233064Copra SupremeK232952Copran Zri

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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