DentCare正畸器
K号: K222918 · 2022-11-25
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决定日期2022-11-25
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
DentCare Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Dentcare Dental Lab Pvt , Ltd.. It received FDA 510(k) clearance on 2022-11-25 under 510(k) number K222918. 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 DentCare Aligners?
DentCare Aligners is a medical device that received FDA 510(k) clearance on 2022-11-25. The listed applicant is Dentcare Dental Lab Pvt , Ltd.. The 510(k) number is K222918.
When did DentCare Aligners receive FDA 510(k) clearance?
DentCare Aligners received FDA 510(k) clearance on 2022-11-25, under 510(k) number K222918.
Who is the listed applicant for DentCare Aligners?
The FDA 510(k) record lists Dentcare Dental Lab Pvt , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DentCare Aligners?
The FDA product code for DentCare Aligners 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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