# K253282: ZSmile System

- Pathway: 510(k) (Special)
- Applicant: Dror Orthodesign, Ltd.
- Decided: Feb 3, 2026 after 127 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192069: Aerodentis System, Dror Orthodesign (2020) Summary page 5.

## Indications for use
The ZSmile System is indicated for use in movement and alignment of teeth during orthodontic treatment of malocclusion.

Source page: https://510kreport.com/device/K253282
Methodology: https://510kreport.com/methodology