FDA 510(k)

FREEPRINT 冠状牙套

K号: K222877 · 2022-09-23

决定日期2022-09-23

产品代码EBF

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决定实质等同

器械摘要

FREEPRINT crown is the device name listed in this FDA 510(k) record. The listed applicant is Detax GmbH. It received FDA 510(k) clearance on 2022-09-23 under 510(k) number K222877. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FREEPRINT crown?

FREEPRINT crown is a medical device that received FDA 510(k) clearance on 2022-09-23. The listed applicant is Detax GmbH. The 510(k) number is K222877.

When did FREEPRINT crown receive FDA 510(k) clearance?

FREEPRINT crown received FDA 510(k) clearance on 2022-09-23, under 510(k) number K222877.

Who is the listed applicant for FREEPRINT crown?

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

What is the FDA product code for FREEPRINT crown?

The FDA product code for FREEPRINT crown is EBF.

列明Detax 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。

K252430Freeprint® 牙托弹性 K232448FREEPRINT® 支具大师

官方来源

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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。