# K233935: DigiLine Direct Print Aligner System

- Pathway: 510(k) (Traditional)
- Applicant: Park Dental Research Corporation
- Decided: Apr 5, 2024 after 113 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: 8 generations back to K780619 (1978). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223355: Tera Harz Clear, Graphy, Inc. (2022) Summary page 5.

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

Source page: https://510kreport.com/device/K233935
Methodology: https://510kreport.com/methodology