FDA 510(k)

Copran Zri

K号: K232952 · 2024-06-24

决定日期2024-06-24

产品代码EIH

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决定实质等同

器械摘要

Copran Zri 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 2024-06-24 under 510(k) number K232952. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Copran Zri?

Copran Zri is a medical device that received FDA 510(k) clearance on 2024-06-24. The listed applicant is Whitepeaks Dental Solutions GmbH. The 510(k) number is K232952.

When did Copran Zri receive FDA 510(k) clearance?

Copran Zri received FDA 510(k) clearance on 2024-06-24, under 510(k) number K232952.

Who is the listed applicant for Copran Zri?

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 Copran Zri?

The FDA product code for Copran Zri is EIH.

列明Whitepeaks Dental Solutions GmbH为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K233064Copra Supreme K233158Copra Smile, Copra Supreme Hyperion

官方来源

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