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FDA 510(k)

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

K-Number: K211190 · 2021-04-23

Applicant3M Company, Unitek Orthodontic Products
Decision Date2021-04-23
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) is a medical device manufactured by 3M Company, Unitek Orthodontic Products. It received FDA 510(k) clearance on 2021-04-23 under approval number K211190. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by 3M Company, Unitek Orthodontic Products. The 510(k) number is K211190.

When was 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) approved by the FDA?

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

What company makes 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)?

3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) is manufactured by 3M Company, Unitek Orthodontic Products.

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.

Other Devices by 3M Company, Unitek Orthodontic Products

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

Related Devices (Code: NXC)

K151965Dentti SystemMartz, Inc. K162609ClearPath AlignerClearpath Orthodontics, Ltd. K163155MTM Clear AlignerDentsply Sirona K1636893M Clear Tray Aligner3M Unitek Corporation K1831593M Clarity Aligners3M Company K182329SureCure Orthodontic Aligner SystemDigital Orthodontic Care

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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