FDA 510(k)

3.0动态TiBase

K号: K162021 · 2018-05-04

决定日期2018-05-04

产品代码NHA

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决定实质等同

器械摘要

3.0 Dynamic TiBase is the device name listed in this FDA 510(k) record. The listed applicant is Talladium Espana, SL. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K162021. 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 3.0 Dynamic TiBase?

3.0 Dynamic TiBase is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Talladium Espana, SL. The 510(k) number is K162021.

When did 3.0 Dynamic TiBase receive FDA 510(k) clearance?

3.0 Dynamic TiBase received FDA 510(k) clearance on 2018-05-04, under 510(k) number K162021.

Who is the listed applicant for 3.0 Dynamic TiBase?

The FDA 510(k) record lists Talladium Espana, SL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3.0 Dynamic TiBase?

The FDA product code for 3.0 Dynamic TiBase is NHA.

列明Talladium Espana, SL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。

K221966Dynamic TiBase

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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