FDA 510(k)

Medentika CAD/CAM TiBases

K号: K170838 · 2017-09-15

决定日期2017-09-15

产品代码NHA

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决定实质等同

器械摘要

Medentika CAD/CAM TiBases is the device name listed in this FDA 510(k) record. The listed applicant is Medentika GmbH. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K170838. 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 Medentika CAD/CAM TiBases?

Medentika CAD/CAM TiBases is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Medentika GmbH. The 510(k) number is K170838.

When did Medentika CAD/CAM TiBases receive FDA 510(k) clearance?

Medentika CAD/CAM TiBases received FDA 510(k) clearance on 2017-09-15, under 510(k) number K170838.

Who is the listed applicant for Medentika CAD/CAM TiBases?

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

What is the FDA product code for Medentika CAD/CAM TiBases?

The FDA product code for Medentika CAD/CAM TiBases is NHA.

列明Medentika 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。

K253341定制基台 AS K242542Medentika CAD/CAM 支撑 K223113Medentika 支撑系统，Medentika CAD/CAM 支撑，Medentika CAD/CAM TiBases，Medentika 多单元支撑 K201711CARES螺钉 - 保留条和桥（SRBB）K200906MINICONE Implant K191123多单位基台

查看所有 8 个设备 →

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

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