FDA 510(k)

Cortex CAD/CAM基台

K号: K181580 · 2019-01-29

申请人Cortex Dental Implants Industries , Ltd.

决定日期2019-01-29

产品代码NHA

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

Cortex CAD/CAM Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Cortex Dental Implants Industries , Ltd.. It received FDA 510(k) clearance on 2019-01-29 under 510(k) number K181580. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cortex CAD/CAM Abutments?

Cortex CAD/CAM Abutments is a medical device that received FDA 510(k) clearance on 2019-01-29. The listed applicant is Cortex Dental Implants Industries , Ltd.. The 510(k) number is K181580.

When did Cortex CAD/CAM Abutments receive FDA 510(k) clearance?

Cortex CAD/CAM Abutments received FDA 510(k) clearance on 2019-01-29, under 510(k) number K181580.

Who is the listed applicant for Cortex CAD/CAM Abutments?

The FDA 510(k) record lists Cortex Dental Implants Industries , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cortex CAD/CAM Abutments?

The FDA product code for Cortex CAD/CAM Abutments is NHA.

列明Cortex Dental Implants Industries , Ltd.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。

K163385Cortex牙种植系统

相关器械（代码：NHA）

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。

K262207水泥固定基台Unidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLC K253999通用底座 ASC 启动；通用底座 ASC 非启动；通用底座 MUA ASC；临时基台启动和非启动；愈合基台锥形连接；Omnigrip 临床螺丝钛；Omnigrip 假体螺丝Nobel Biocare AB K261147Neodent植入系统 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

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。