# K230199: Byte Aligner System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona, Inc.
- Decided: Oct 18, 2023 after 266 days
- 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: 6 generations back to K780619 (1978). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180346: Byte Aligner System, Straight Smile, LLC (2019) Summary page 5.

## Recalls of this device
- Nov 4, 2024 · Class II · Z-0750-2025: Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.

## 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/K230199
Methodology: https://510kreport.com/methodology