# K233257: 3M™ Clarity™Aligners with Quick Attachments

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company, Unitek Orthodontic Products
- Decided: Sep 29, 2023 after 1 day
- Product code: NXC (Aligner, Sequential)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K780619 (1978). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231464: 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex), 3M Company, Unitek Orthodontic Products (2023) Summary page 4.

## Recalls of this device
- Nov 22, 2024 · Class II · Z-0743-2025: Attachments may not mate with the tooth as intended in the digital treatment design.

## Indications for use
3M™ Clarity™ Aligners with Quick Attachments are indicated for the alignment of teeth during orthodontic treatment of malocclusion.

Source page: https://510kreport.com/device/K233257
Methodology: https://510kreport.com/methodology