FDA 510(k)

Sirona 牙科 CAD/CAM 系统带 InLab 软件

K号: K200191 · 2020-08-19

决定日期2020-08-19

产品代码PNP

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

Sirona Dental CAD/CAM System with InLab Software is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K200191. The device is classified under product code PNP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sirona Dental CAD/CAM System with InLab Software?

Sirona Dental CAD/CAM System with InLab Software is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Dentsply Sirona. The 510(k) number is K200191.

When did Sirona Dental CAD/CAM System with InLab Software receive FDA 510(k) clearance?

Sirona Dental CAD/CAM System with InLab Software received FDA 510(k) clearance on 2020-08-19, under 510(k) number K200191.

Who is the listed applicant for Sirona Dental CAD/CAM System with InLab Software?

FDA 510(k)记录中列出Dentsply Sirona为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Sirona Dental CAD/CAM System with InLab Software?

The FDA product code for Sirona Dental CAD/CAM System with InLab Software is PNP.

列明Dentsply Sirona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。

K262127DS Core CBCT 解剖 K260785DS Core CBCT 解剖 K253959Primevision 3D K252343Atlantis® 钛基台 K252248CEREC Tessera基台系统 K251205Atlantis® 钛基台，用于 Straumann BLX 和 Neodent GM 植入体

查看所有 66 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。