FDA 510(k)

表面纳米清漆，Plaquit，Lightpaint

K号: K162408 · 2018-04-05

决定日期2018-04-05

产品代码EBD

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

Nano Varnish, Plaquit, Lightpaint on Surface is the device name listed in this FDA 510(k) record. The listed applicant is Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K162408. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nano Varnish, Plaquit, Lightpaint on Surface?

Nano Varnish, Plaquit, Lightpaint on Surface is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Dreve Dentamid GmbH. The 510(k) number is K162408.

When did Nano Varnish, Plaquit, Lightpaint on Surface receive FDA 510(k) clearance?

Nano Varnish, Plaquit, Lightpaint on Surface received FDA 510(k) clearance on 2018-04-05, under 510(k) number K162408.

Who is the listed applicant for Nano Varnish, Plaquit, Lightpaint on Surface?

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

What is the FDA product code for Nano Varnish, Plaquit, Lightpaint on Surface?

The FDA product code for Nano Varnish, Plaquit, Lightpaint on Surface is EBD.

列明Dreve Dentamid 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。

K250739Primeprint直接矫正器 K200580FotoDent 假牙 K190571StoneBite 和 StoneBite 扫描 K171562Dynax 清晰型，Dynax 腊状，Dynax 重型，Dynax 轻型，Dynax 单一型 K171729Fixtemp C&B

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。