# K173785: Custom Clear Aligner System

- Pathway: 510(k) (Traditional)
- Applicant: Derby Dental Laboratory
- Decided: Mar 13, 2018 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). 7 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 13 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 4.

## Most influential descendants
- K183643: Clear Image Aligners (2019), 1 descendant of its own
- K200005: Concinnity Aligners (2020), 0 descendants of its own
- K191308: U-Aligner (2020), 0 descendants of its own
- K192470: DenMat Orthodontic Aligners (2019), 0 descendants of its own
- K182658: Bioliner (2019), 0 descendants of its own

## Indications for use
The Custom Clear Aligner System is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

Source page: https://510kreport.com/device/K173785
Methodology: https://510kreport.com/methodology