Z-CAD微笑
K号: K170050 · 2018-08-23
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申请人Metoxit AG
决定日期2018-08-23
产品代码EIH
咨询委员会DE
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决定实质等同
器械摘要
Z-CAD smile is the device name listed in this FDA 510(k) record. The listed applicant is Metoxit AG. It received FDA 510(k) clearance on 2018-08-23 under 510(k) number K170050. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Z-CAD smile?
Z-CAD smile is a medical device that received FDA 510(k) clearance on 2018-08-23. The listed applicant is Metoxit AG. The 510(k) number is K170050.
When did Z-CAD smile receive FDA 510(k) clearance?
Z-CAD smile received FDA 510(k) clearance on 2018-08-23, under 510(k) number K170050.
Who is the listed applicant for Z-CAD smile?
The FDA 510(k) record lists Metoxit AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Z-CAD smile?
The FDA product code for Z-CAD smile is EIH.
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。
相关器械（代码：EIH）
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。
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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