# K180346: Byte Aligner System

- Pathway: 510(k) (Traditional)
- Applicant: Straight Smile, LLC
- Decided: Feb 19, 2019 after 376 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). 7 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113618: Clearcorrect System, Clearcorrect, Inc. (2012) Summary page 4.

## Most influential descendants
- K203624: Custom-made Invisible Aligners (2022), 1 descendant of its own
- K230199: Byte Aligner System (2023), 0 descendants of its own
- K223454: Custom-made Invisible Aligners (2023), 0 descendants of its own
- K212961: Smilers (2021), 0 descendants of its own
- K191774: SmileAlign Orthodontic Aligner System (2019), 0 descendants of its own

## Indications for use
The Byte Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Byte Aligner System positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K180346
Methodology: https://510kreport.com/methodology