FDA 510(k)

3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)

K号: K211190 · 2021-04-23

申请人3M Company, Unitek Orthodontic Products

决定日期2021-04-23

产品代码NXC

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决定实质等同

器械摘要

3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company, Unitek Orthodontic Products. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K211190. 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 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)?

3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is 3M Company, Unitek Orthodontic Products. The 510(k) number is K211190.

When did 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) receive FDA 510(k) clearance?

3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) received FDA 510(k) clearance on 2021-04-23, under 510(k) number K211190.

Who is the listed applicant for 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)?

The FDA 510(k) record lists 3M Company, Unitek Orthodontic Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)?

The FDA product code for 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) is NXC.

列明3M Company, Unitek Orthodontic Products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。

K2332573M® Clarity®Aligners with Quick Attachments K2314643M® Clarity® Aligners (3M® Clarity® Aligners-Force, 3M® Clarity® Aligners-Flex)

官方来源

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