FDA 510(k)

Dentca Base Premium，Dentca Base Hi-Impact

K号: K220042 · 2022-11-17

决定日期2022-11-17

产品代码EBI

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

Dentca Base Premium, Dentca Base Hi-Impact is the device name listed in this FDA 510(k) record. The listed applicant is Dentca, Inc.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K220042. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dentca Base Premium, Dentca Base Hi-Impact?

Dentca Base Premium, Dentca Base Hi-Impact is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Dentca, Inc.. The 510(k) number is K220042.

When did Dentca Base Premium, Dentca Base Hi-Impact receive FDA 510(k) clearance?

Dentca Base Premium, Dentca Base Hi-Impact received FDA 510(k) clearance on 2022-11-17, under 510(k) number K220042.

Who is the listed applicant for Dentca Base Premium, Dentca Base Hi-Impact?

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

What is the FDA product code for Dentca Base Premium, Dentca Base Hi-Impact?

The FDA product code for Dentca Base Premium, Dentca Base Hi-Impact is EBI.

列明Dentca, Inc.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。

K261474DENTCA Tru Flexible K192806DENTCA 冠桥 K172398DENTCA 假牙牙齿 K162044Dentca Denture Base II

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。