# K180648: Park Dental Research Aligners

- Pathway: 510(k) (Traditional)
- Applicant: Park Dental Research Corporation
- Decided: Jan 8, 2019 after 301 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.
No later device cites it as a predicate yet.
0 of 8 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 1.

## Indications for use
Park Dental Research Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Park Dental Research Aligners positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K180648
Methodology: https://510kreport.com/methodology