# K123118: Insignia Digicast

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corp.
- Decided: Mar 26, 2013 after 174 days
- Product code: DYW (Bracket, Plastic, Orthodontic)
- 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: 1 generation back to K082207 (2009). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082207: Orthocad IQ, Cadent, Inc. (2009) Summary page 1.
- (no number) Lava Digital Models: named in the summary without a submission number

## Most influential descendants
- K181271: Signature Orthodontic System (2018), 4 descendants of its own
- K222764: LightForce Orthodontic System (2022), 1 descendant of its own
- K183542: Signature Orthodontic System (2019), 1 descendant of its own
- K232827: LightForce Orthodontic System (2023), 0 descendants of its own
- K200148: LightForce Orthodontic System (LFO System) (2020), 0 descendants of its own

## Indications for use
Insignia Digicast is a computer aided system intended for use as an aid in orthodontic diagnostics for use by dental professionals trained in orthodontic treatment including radiographic analyses and diagnostics.

Source page: https://510kreport.com/device/K123118
Methodology: https://510kreport.com/methodology