# K210652: 6MS Invisible Aligner

- Pathway: 510(k) (Traditional)
- Applicant: Sms Opco, LLC
- Decided: Jun 2, 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: 5 generations back to K780619 (1978). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182826: Ormco Spark Aligner System, Sybron Dental Specialties (2018) Summary page 4.

## Indications for use
6MS Invisible Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars). The 6MS Invisible Aligner positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K210652
Methodology: https://510kreport.com/methodology