# K113618: Clearcorrect System

- Pathway: 510(k) (Traditional)
- Applicant: Clearcorrect, Inc.
- Decided: Mar 19, 2012 after 103 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). 6 ancestors in all.
60 later devices descend from it; 16 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082556: Clearcorrect, Clearcorrect, Inc. (2009) Summary page 1.
- K093821: FS Aligner, Allesee Orthodontic Appliances (2010) Summary page 1.

## Most influential descendants
- K180241: Orthocaps Twinaligner (2018), 15 descendants of its own
- K163689: 3M Clear Tray Aligner (2017), 13 descendants of its own
- K192596: ULab Systems Dental Aligner Kit (2020), 8 descendants of its own
- K180346: Byte Aligner System (2019), 5 descendants of its own
- K173785: Custom Clear Aligner System (2018), 5 descendants of its own

## Indications for use
The ClearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K113618
Methodology: https://510kreport.com/methodology