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FDA 510(k)

Luna 牙科种植系统- 恢复基台

K号: K200189 · 2020-02-26

申请人Shinhung Mst Co., Ltd.
决定日期2020-02-26
产品代码NHA
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决定实质等同

器械摘要

Luna Dental Implant System- Healing Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Shinhung Mst Co., Ltd.. It received FDA 510(k) clearance on 2020-02-26 under 510(k) number K200189. 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 Luna Dental Implant System- Healing Abutment?

Luna Dental Implant System- Healing Abutment is a medical device that received FDA 510(k) clearance on 2020-02-26. The listed applicant is Shinhung Mst Co., Ltd.. The 510(k) number is K200189.

When did Luna Dental Implant System- Healing Abutment receive FDA 510(k) clearance?

Luna Dental Implant System- Healing Abutment received FDA 510(k) clearance on 2020-02-26, under 510(k) number K200189.

Who is the listed applicant for Luna Dental Implant System- Healing Abutment?

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

What is the FDA product code for Luna Dental Implant System- Healing Abutment?

The FDA product code for Luna Dental Implant System- Healing 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Shinhung Mst Co., 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。

K221752StellaK223395Luna 牙科种植系统K221317S-MonoK162867MagDen牙种植系统K160106LUNA 牙科种植系统

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, 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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