FDA 510(k)

Luna 牙科种植系统

K号: K223395 · 2023-02-03

决定日期2023-02-03

产品代码NHA

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决定实质等同

器械摘要

Luna Dental Implant System 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 2023-02-03 under 510(k) number K223395. 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?

Luna Dental Implant System is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is Shinhung Mst Co., Ltd.. The 510(k) number is K223395.

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

Luna Dental Implant System received FDA 510(k) clearance on 2023-02-03, under 510(k) number K223395.

Who is the listed applicant for Luna Dental Implant System?

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?

The FDA product code for Luna Dental Implant System is NHA.

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。

K221752Stella K221317S-Mono K200189Luna 牙科种植系统- 恢复基台 K162867MagDen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, LLC K253999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 AB K261147Neodent植入系统 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

官方来源

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