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FDA 510(k)

定制传统和定制互动钛基台

K号: K192218 · 2020-05-08

申请人Implant Direct Sybron Manufacturing, LLC
决定日期2020-05-08
产品代码NHA
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决定实质等同

器械摘要

Custom Legacy and Custom InterActive Titanium Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2020-05-08 under 510(k) number K192218. 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 Custom Legacy and Custom InterActive Titanium Abutments?

Custom Legacy and Custom InterActive Titanium Abutments is a medical device that received FDA 510(k) clearance on 2020-05-08. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K192218.

When did Custom Legacy and Custom InterActive Titanium Abutments receive FDA 510(k) clearance?

Custom Legacy and Custom InterActive Titanium Abutments received FDA 510(k) clearance on 2020-05-08, under 510(k) number K192218.

Who is the listed applicant for Custom Legacy and Custom InterActive Titanium Abutments?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Custom Legacy and Custom InterActive Titanium Abutments?

The FDA product code for Custom Legacy and Custom InterActive Titanium Abutments 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Implant Direct Sybron Manufacturing, LLC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。

K231087引导手术套件K223535SMARTbase 牙槽基台系统K222211Implant Direct 牙齿植入系统组合 - MR 条件K202524标准可灭菌托盘K201553Simply Iconic ImplantsK200858微型可灭菌托盘

查看所有 13 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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