Medentika CAD/CAM 支撑
K号: K242542 · 2025-04-22
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决定日期2025-04-22
产品代码NHA
咨询委员会DE
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决定实质等同
器械摘要
Medentika CAD/CAM Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Medentika GmbH. It received FDA 510(k) clearance on 2025-04-22 under 510(k) number K242542. 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 Medentika CAD/CAM Abutments?
Medentika CAD/CAM Abutments is a medical device that received FDA 510(k) clearance on 2025-04-22. The listed applicant is Medentika GmbH. The 510(k) number is K242542.
When did Medentika CAD/CAM Abutments receive FDA 510(k) clearance?
Medentika CAD/CAM Abutments received FDA 510(k) clearance on 2025-04-22, under 510(k) number K242542.
Who is the listed applicant for Medentika CAD/CAM Abutments?
The FDA 510(k) record lists Medentika GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Medentika CAD/CAM Abutments?
The FDA product code for Medentika CAD/CAM Abutments 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。
列明Medentika GmbH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。
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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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