# K203737: Spark Clear Aligner System

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corporation
- Decided: Mar 22, 2021 after 90 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.
10 later devices descend from it; 2 cite it directly.
0 of 15 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
- K212660: Smylio Invisible Clear Aligners (2021), 7 descendants of its own
- K211510: uLab Systems Dental Aligner Kit (2022), 2 descendants of its own
- K240501: Spark™ Clear Aligner System (2024), 1 descendant of its own
- K233356: Illusion Aligner Pro: Illusion Aligner FLX (2024), 1 descendant of its own
- K223141: STR8 Clear Aligner (2023), 1 descendant of its own

## Indications for use
Spark™ Clear Aligner System: The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion. Spark™ Software System: The Spark™ Software System is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays, retainers or bracket bonding templatesor based on 3D models of the patient’s dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of the Spark™ Clear Aligner System and Spark™ Software System requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

Source page: https://510kreport.com/device/K203737
Methodology: https://510kreport.com/methodology