FDA 510(k)

Alpha Dent Implants牙科植入系统

K号: K240435 · 2024-12-20

决定日期2024-12-20

产品代码DZE

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

Alpha Dent Implants Dental Implants System is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Dent Implants GmbH. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K240435. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Alpha Dent Implants Dental Implants System?

Alpha Dent Implants Dental Implants System is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Alpha Dent Implants GmbH. The 510(k) number is K240435.

When did Alpha Dent Implants Dental Implants System receive FDA 510(k) clearance?

Alpha Dent Implants Dental Implants System received FDA 510(k) clearance on 2024-12-20, under 510(k) number K240435.

Who is the listed applicant for Alpha Dent Implants Dental Implants System?

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

What is the FDA product code for Alpha Dent Implants Dental Implants System?

The FDA product code for Alpha Dent Implants Dental Implants System is DZE.

列明Alpha Dent Implants 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。

K210499Alpha Dent Implants牙科植入系统

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。