# K182826: Ormco Spark Aligner System

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties
- Decided: Oct 11, 2018 after 6 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: 4 generations back to K780619 (1978). 4 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143630: Invisalign System, Align Technology, Inc. (2015) Summary page 4.

## Most influential descendants
- K210540: Ohlendorf Clear Aligner (2021), 1 descendant of its own
- K241137: Clear Moves Aligner (2024), 0 descendants of its own
- K210652: 6MS Invisible Aligner (2021), 0 descendants of its own
- K203339: NEOLab Clear Aligners (2021), 0 descendants of its own
- K202685: Eon Aligner (2020), 0 descendants of its own

## Indications for use
The Ormco™ Spark™ Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The Ormco™ Spark™ Aligner System positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K182826
Methodology: https://510kreport.com/methodology