FDA 510(k)

NextDent 正畸柔性

K号: K221022 · 2022-10-21

决定日期2022-10-21

产品代码MQC

决定实质等同

器械摘要

NextDent Ortho Flex is the device name listed in this FDA 510(k) record. The listed applicant is Vertex-Dental B.V.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K221022. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常见问题

What is the NextDent Ortho Flex?

NextDent Ortho Flex is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Vertex-Dental B.V.. The 510(k) number is K221022.

When did NextDent Ortho Flex receive FDA 510(k) clearance?

NextDent Ortho Flex received FDA 510(k) clearance on 2022-10-21, under 510(k) number K221022.

Who is the listed applicant for NextDent Ortho Flex?

The FDA 510(k) record lists Vertex-Dental B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NextDent Ortho Flex?

The FDA product code for NextDent Ortho Flex is MQC.

列明Vertex-Dental B.V.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。

K241071NextDent 喷射假牙基础；NextDent 喷射假牙牙齿 K231388NextDent 基础版 K191497NextDent 假牙 3D+K162572NextDent 假牙，E-Denture

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。