# K171860: Sureclear aligners

- Pathway: 510(k) (Traditional)
- Applicant: Emergo Global Consulting, LLC
- Decided: Jan 5, 2018 after 197 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113618: Clearcorrect System, Clearcorrect, Inc. (2012) Summary page 5.

## Indications for use
Sureclear™ aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition.

Source page: https://510kreport.com/device/K171860
Methodology: https://510kreport.com/methodology