Copra Smile, Copra Supreme Hyperion
K号: K233158 · 2024-06-20
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决定日期2024-06-20
产品代码EIH
咨询委员会DE
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决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
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。
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。
相关器械（代码：EIH）
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。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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