# 3M Company, Unitek Orthodontic Products

- Location (FDA's records): Saint Paul, MN
- FDA decisions: 3 (2021–2023): 3 510(k) clearances
- Product codes: NXC (3)
- 510(k) review time since 2016: median 2 days, against 152 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- 3M Company: 1 (https://510kreport.com/company/3m)

## Its most-cited devices
- K211190: 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) (2021), cited by 1
- K231464: 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) (2023), cited by 1

## Recent decisions
- K233257: 3M™ Clarity™Aligners with Quick Attachments (Sep 29, 2023)
- K231464: 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) (May 22, 2023)
- K211190: 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) (Apr 23, 2021)

Source page: https://510kreport.com/company/3m-company-unitek-orthodontic-products