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FDA 510(k)

Omni 方向多单元基台系统（商品名：Omnibut™）

K号: K242064 · 2025-01-17

申请人Smart Denture Conversions, LLC
决定日期2025-01-17
产品代码NHA
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决定实质等同

器械摘要

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) is the device name listed in this FDA 510(k) record. The listed applicant is Smart Denture Conversions, LLC. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K242064. 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 Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)?

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Smart Denture Conversions, LLC. The 510(k) number is K242064.

When did Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) receive FDA 510(k) clearance?

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) received FDA 510(k) clearance on 2025-01-17, under 510(k) number K242064.

Who is the listed applicant for Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)?

The FDA 510(k) record lists Smart Denture Conversions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)?

The FDA product code for Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) 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Smart Denture Conversions, 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。

K254145Omni 方向多单元基台系统（商品名：Omnibut™）

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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