# K163689: 3M Clear Tray Aligner

- Pathway: 510(k) (Traditional)
- Applicant: 3M Unitek Corporation
- Decided: Jan 27, 2017 after 30 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: 5 generations back to K780619 (1978). 8 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 22 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 5.
- K113618: Clearcorrect System, Clearcorrect, Inc. (2012) Summary page 5.

## Most influential descendants
- K183159: 3M Clarity Aligners (2018), 4 descendants of its own
- K180107: Blue Sky Bio Aligner (2018), 4 descendants of its own
- K192119: 3M Clarity Aligners (2019), 3 descendants of its own
- K223355: Tera Harz Clear (2022), 2 descendants of its own
- K211190: 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) (2021), 2 descendants of its own

## Indications for use
The 3M™ Clear Tray Aligner system is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K163689
Methodology: https://510kreport.com/methodology