FDA 510(k)

Medentika 支撑系统，Medentika CAD/CAM 支撑，Medentika CAD/CAM TiBases

K号: K180564 · 2019-01-07

决定日期2019-01-07

产品代码NHA

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决定实质等同

器械摘要

Medentika Abutment System, Medentika CAD/CAM Abutments, 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 2019-01-07 under 510(k) number K180564. 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 Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases?

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases is a medical device that received FDA 510(k) clearance on 2019-01-07. The listed applicant is Medentika GmbH. The 510(k) number is K180564.

When did Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases receive FDA 510(k) clearance?

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases received FDA 510(k) clearance on 2019-01-07, under 510(k) number K180564.

Who is the listed applicant for Medentika Abutment System, Medentika CAD/CAM Abutments, 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 Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases?

The FDA product code for Medentika Abutment System, Medentika CAD/CAM Abutments, 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

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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。

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官方来源

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