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FDA 510(k)

SmartShape®修复基台；宽定制铣削Ti-Blank基台

K号: K240531 · 2024-07-30

申请人BioHorizons Implant Systems, Inc.
决定日期2024-07-30
产品代码NHA
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决定实质等同

器械摘要

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is the device name listed in this FDA 510(k) record. The listed applicant is BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2024-07-30 under 510(k) number K240531. 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 SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is a medical device that received FDA 510(k) clearance on 2024-07-30. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K240531.

When did SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment receive FDA 510(k) clearance?

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment received FDA 510(k) clearance on 2024-07-30, under 510(k) number K240531.

Who is the listed applicant for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

The FDA 510(k) record lists BioHorizons Implant Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

The FDA product code for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment 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BioHorizons Implant Systems, Inc.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。

K260061BioHorizons CEREC 兼容 Ti-BasesK243521锥形钛基托K240187锥形植入系统K223697现有 BioHorizons 牙种植体和基台兼容 MRIK203252针对CONELOG的多单位基台K182070BioHorizons Tapered IM Implants

查看所有 10 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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