Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K231464 · 2023-05-22

Decision Date2023-05-22
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 2023-05-22 under approval number K231464. 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 2023-05-22. It is manufactured by 3M Company, Unitek Orthodontic Products. The 510(k) number is K231464.

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 2023-05-22, under approval number K231464.

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

Related Devices (Code: NXC)

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.