# K212660: Smylio Invisible Clear Aligners

- Pathway: 510(k) (Special)
- Applicant: Smylio, Inc.
- Decided: Sep 22, 2021 after 30 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). 6 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203737: Spark Clear Aligner System, Ormco Corporation (2021) Summary page 4.
- K173784: Smylic Invisible Clear Aligners, Smylio, Inc. (2018) Summary page 4.

## Most influential descendants
- K211510: uLab Systems Dental Aligner Kit (2022), 2 descendants 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
- K220726: K Clear (2022), 1 descendant of its own
- K260527: FACE4D Aligner (2026), 0 descendants of its own

## Indications for use
The Smylio Invisible Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.

Source page: https://510kreport.com/device/K212660
Methodology: https://510kreport.com/methodology