# K221097: SmileSeries

- Pathway: 510(k) (Traditional)
- Applicant: Ordont Orthodontic Laboratories, Inc.
- Decided: Jul 14, 2022 after 91 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.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202857: ClearPath Aligner, Clearpath Orthodontics, Ltd. (2021) Summary page 4.

## Most influential descendants
- K241137: Clear Moves Aligner (2024), 0 descendants of its own

## Indications for use
The SmileSeriesTM is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in adult and adolescent patients with permanent dentition (i.e. all second molars). The SmileSeriesTM positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K221097
Methodology: https://510kreport.com/methodology