# K123514: Clearpath Aligner

- Pathway: 510(k) (Traditional)
- Applicant: Qserve America, Inc.
- Decided: Nov 1, 2013 after 352 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: 3 generations back to K780619 (1978). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073121: Nubrace Invisible Removable Orthodontics, Nubrace, Inc. (2009) Summary page 1.
- K981095: Align System, Align Technology (1998) Summary page 1.

## Most influential descendants
- K162609: ClearPath Aligner (2017), 4 descendants of its own
- K202857: ClearPath Aligner (2021), 3 descendants of its own
- K221097: SmileSeries (2022), 1 descendant of its own
- K241137: Clear Moves Aligner (2024), 0 descendants of its own
- K211537: QuickAligners (2021), 0 descendants of its own

## Indications for use
The ClearPath Aligner Is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentitian (i.e. all second molars). The ClearPath Aligner is intended for minor anterior tooth movement by way of continuous gentle force.

Source page: https://510kreport.com/device/K123514
Methodology: https://510kreport.com/methodology