# K183159: 3M Clarity Aligners

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Nov 26, 2018 after 11 days
- Product code: NXC (Aligner, Sequential)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K780619 (1978). 9 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081960: Invisalign System, Align Technology (2008) Summary page 7.
- K163689: 3M Clear Tray Aligner, 3M Unitek Corporation (2017) Summary page 7.

## Most influential descendants
- K192119: 3M Clarity Aligners (2019), 3 descendants of its own
- K211190: 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) (2021), 2 descendants of its own
- K231464: 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) (2023), 1 descendant of its own
- K233257: 3M™ Clarity™Aligners with Quick Attachments (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K183159
Methodology: https://510kreport.com/methodology