# K190948: Magic Clear Aligners

- Pathway: 510(k) (Traditional)
- Applicant: Voodoo Manufacturing, Inc.
- Decided: May 9, 2019 after 28 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180241: Orthocaps Twinaligner, Ortho Caps GmbH (2018) Summary page 4.

## Indications for use
Magic Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

Source page: https://510kreport.com/device/K190948
Methodology: https://510kreport.com/methodology