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FDA 510(k)

Speedex 轻型体;Speedex 中型;Speedex 灰泥;Speedex 灰泥软;Speedex 通用激活器

K号: K242360 · 2024-11-15

申请人Dent4you AG
决定日期2024-11-15
产品代码ELW
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

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator is the device name listed in this FDA 510(k) record. The listed applicant is Dent4you AG. It received FDA 510(k) clearance on 2024-11-15 under 510(k) number K242360. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator?

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is Dent4you AG. The 510(k) number is K242360.

When did Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator receive FDA 510(k) clearance?

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator received FDA 510(k) clearance on 2024-11-15, under 510(k) number K242360.

Who is the listed applicant for Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator?

The FDA 510(k) record lists Dent4you AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator?

The FDA product code for Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator is ELW.

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Dent4you AG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:ELW)

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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