QuickAligners
K号: K211537 · 2021-10-26
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决定日期2021-10-26
产品代码NXC
咨询委员会DE
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决定实质等同
器械摘要
QuickAligners is the device name listed in this FDA 510(k) record. The listed applicant is Oral Image, Inc.. It received FDA 510(k) clearance on 2021-10-26 under 510(k) number K211537. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the QuickAligners?
QuickAligners is a medical device that received FDA 510(k) clearance on 2021-10-26. The listed applicant is Oral Image, Inc.. The 510(k) number is K211537.
When did QuickAligners receive FDA 510(k) clearance?
QuickAligners received FDA 510(k) clearance on 2021-10-26, under 510(k) number K211537.
Who is the listed applicant for QuickAligners?
The FDA 510(k) record lists Oral Image, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for QuickAligners?
The FDA product code for QuickAligners is NXC.
相关临床试验
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相关器械（代码：NXC）
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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