iTero Lumina™ Pro
K号: K240573 · 2024-08-16
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决定日期2024-08-16
产品代码NTK
咨询委员会DE
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器械摘要
iTero Lumina™ Pro is the device name listed in this FDA 510(k) record. The listed applicant is Align Technology , Ltd.. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K240573. The device is classified under product code NTK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the iTero Lumina™ Pro?
iTero Lumina™ Pro is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is Align Technology , Ltd.. The 510(k) number is K240573.
When did iTero Lumina™ Pro receive FDA 510(k) clearance?
iTero Lumina™ Pro received FDA 510(k) clearance on 2024-08-16, under 510(k) number K240573.
Who is the listed applicant for iTero Lumina™ Pro?
The FDA 510(k) record lists Align Technology , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iTero Lumina™ Pro?
The FDA product code for iTero Lumina™ Pro is NTK.
相关临床试验
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列明Align Technology , 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。
相关器械（代码：NTK）
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。
K261847iTero Lumina™ ProAlign Technology , Ltd.K250771Primescan 2Dentsply Sirona, Inc.K213482TIA Tip, Cariosity, Transillumination Accessory TipD4D Technologies, LLCK193659伊特罗元素5DAlign Technology, Inc.K182712KaVo DEXIS CariVu 3-in-1Kaltenbach & Voigt GmbHK172007CamX Triton HD Proxi HeadDuerr Dental AG
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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