FDA 510(k)

Straumann 4 毫米短植入体

K号: K202942 · 2021-02-08

决定日期2021-02-08

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

Straumann 4 mm Short Implants is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC. It received FDA 510(k) clearance on 2021-02-08 under 510(k) number K202942. 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 Straumann 4 mm Short Implants?

Straumann 4 mm Short Implants is a medical device that received FDA 510(k) clearance on 2021-02-08. The listed applicant is Straumann USA, LLC. The 510(k) number is K202942.

When did Straumann 4 mm Short Implants receive FDA 510(k) clearance?

Straumann 4 mm Short Implants received FDA 510(k) clearance on 2021-02-08, under 510(k) number K202942.

Who is the listed applicant for Straumann 4 mm Short Implants?

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

What is the FDA product code for Straumann 4 mm Short Implants?

The FDA product code for Straumann 4 mm Short Implants is DZE.

列明Straumann USA, LLC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。

K241575Straumann® 解剖愈合基台 XC (AHA)K203753Straumann 外科托盘 K192401Straumann 螺丝固定基台 K190662现有 Straumann 牙种植系统兼容 MRI K171784Straumann牙种植系统 K162890BLT 02.9mm SC, SLA 或 SLActive, RXD, Loxim, SC Closure Cap 和愈合基台, SC 临时基台, SC Variobase 基台, SC CARES 基台

查看所有 8 个设备 →

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。