FDA 510(k)

MegaGen牙科植入体基台

K号: K242030 · 2025-01-13

决定日期2025-01-13

产品代码NHA

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决定实质等同

器械摘要

MegaGen Dental Implant Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K242030. 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 MegaGen Dental Implant Abutment?

MegaGen Dental Implant Abutment is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Megagen Implant Co., Ltd.. The 510(k) number is K242030.

When did MegaGen Dental Implant Abutment receive FDA 510(k) clearance?

MegaGen Dental Implant Abutment received FDA 510(k) clearance on 2025-01-13, under 510(k) number K242030.

Who is the listed applicant for MegaGen Dental Implant Abutment?

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

What is the FDA product code for MegaGen Dental Implant Abutment?

The FDA product code for MegaGen Dental Implant Abutment is NHA.

列明Megagen Implant 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。

K251232MegaGen颧骨牙科植入系统 K241972BLUEDIAMOND 种植体 K234142TiGEN基台，PMMA基台和扫描愈合基台 K240754N2 K233450MegaGen牙科植入体基台 - 扫描愈合基台；临时基台；临时圆柱体；舒适帽；愈合帽；愈合帽螺钉；铣削基台；EZ基台；额外EZ基台；EZ圆柱体；ZrGEN基台；多单位基台；多单位角度基台；AXA基台（直）；AXA基台（角度）；基台螺钉；圆柱体螺钉；牙冠螺钉 K231967ARi ExCon 植入系统

查看所有 23 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, 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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