FDA 510(k)

KLOCKNER 牙科植入体基座（II）

K号: K151194 · 2016-01-29

决定日期2016-01-29

产品代码NHA

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决定实质等同

器械摘要

KLOCKNER DENTAL IMPLANT ABUTMENTS (II) is the device name listed in this FDA 510(k) record. The listed applicant is SOADCO, S.L.. It received FDA 510(k) clearance on 2016-01-29 under 510(k) number K151194. 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 KLOCKNER DENTAL IMPLANT ABUTMENTS (II)?

KLOCKNER DENTAL IMPLANT ABUTMENTS (II) is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is SOADCO, S.L.. The 510(k) number is K151194.

When did KLOCKNER DENTAL IMPLANT ABUTMENTS (II) receive FDA 510(k) clearance?

KLOCKNER DENTAL IMPLANT ABUTMENTS (II) received FDA 510(k) clearance on 2016-01-29, under 510(k) number K151194.

Who is the listed applicant for KLOCKNER DENTAL IMPLANT ABUTMENTS (II)?

The FDA 510(k) record lists SOADCO, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLOCKNER DENTAL IMPLANT ABUTMENTS (II)?

The FDA product code for KLOCKNER DENTAL IMPLANT ABUTMENTS (II) is NHA.

列明SOADCO, S.L.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。

K243128Klockner套件 K230103Klockner牙槽 K173642KLOCKNER 外科箱 K170022Klockner Vega TiBase for CEREC K153098KLOCKNER VEGA 牙科植入系统

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

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