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FDA 510(k)

CreoDent Solidex Customized Abutment and Screw

K号: K220390 · 2022-12-02

申请人Creodent Prosthetics, Ltd.
决定日期2022-12-02
产品代码NHA
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决定实质等同

器械摘要

CreoDent Solidex Customized Abutment and Screw is the device name listed in this FDA 510(k) record. The listed applicant is Creodent Prosthetics, Ltd.. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K220390. 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 CreoDent Solidex Customized Abutment and Screw?

CreoDent Solidex Customized Abutment and Screw is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Creodent Prosthetics, Ltd.. The 510(k) number is K220390.

When did CreoDent Solidex Customized Abutment and Screw receive FDA 510(k) clearance?

CreoDent Solidex Customized Abutment and Screw received FDA 510(k) clearance on 2022-12-02, under 510(k) number K220390.

Who is the listed applicant for CreoDent Solidex Customized Abutment and Screw?

The FDA 510(k) record lists Creodent Prosthetics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CreoDent Solidex Customized Abutment and Screw?

The FDA product code for CreoDent Solidex Customized Abutment and Screw is NHA.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Creodent Prosthetics, 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。

K211427CREOKORREKT 矫治器K202909CreoDent Solidex Customized AbutmentK202095CreoDent Solidex Customized Abutment and ScrewK170100CreoDent Solidex Customized Abutment and ScrewK162734CreoDent Solidex Customized AbutmentK160436CreoDent Solidex Custom Abutment

查看所有 7 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, LLCK253999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 ABK261147Neodent植入系统 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

官方来源

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