510(k) · Cleared
ClearedInsignia Digicast
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ormco Corp. · DYW Bracket, Plastic, Orthodontic
Cleared on Mar 26, 2013 as substantially equivalent to K082207 (Cadent, Inc., 2009) after a 174-day review. Its family tree reaches back 1 generation to 2009. 5 later devices descend from it.
- Decided
- Mar 26, 2013
- Review
- 174 days
- Class
- Class II
- Product code
- DYW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082207 (2009). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK082207 Orthocad IQCadent, Inc. · 2009
- This deviceK123118 Insignia DigicastOrmco Corp. · 2013
- Descendant · cites it directly · 4 of its ownK181271 Signature Orthodontic SystemSignature Orthodontics · 2018
- Descendant · 2 generations on · 1 of its ownK222764 LightForce Orthodontic SystemLightforce Orthodontics · 2022
- Descendant · 2 generations on · 1 of its ownK183542 Signature Orthodontic SystemSignature Orthodontics · 2019
- Descendant · 3 generations on · 0 of its ownK232827 LightForce Orthodontic SystemLightforce Orthodontics · 2023
- Descendant · 3 generations on · 0 of its ownK200148 LightForce Orthodontic System (LFO System)Lightforce Orthodontics · 2020
Most influential descendants
Showing 5 of 5 · See all- K181271Signature Orthodontic SystemSignature Orthodontics · 2018 · cites it directly4descendants
- K222764LightForce Orthodontic SystemLightforce Orthodontics · 2022 · 2 generations on1descendant
- K183542Signature Orthodontic SystemSignature Orthodontics · 2019 · 2 generations on1descendant
- K232827LightForce Orthodontic SystemLightforce Orthodontics · 2023 · 3 generations on0descendants
- K200148LightForce Orthodontic System (LFO System)Lightforce Orthodontics · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082207 | Orthocad IQ | Cadent, Inc. | 2009 | — |
| 0 (this device) | K123118 | Insignia Digicast | Ormco Corp. | 2013 | — |
| +1 | K181271 | Signature Orthodontic System | Signature Orthodontics | 2018 | — |
| +2 | K222764 | LightForce Orthodontic System | Lightforce Orthodontics | 2022 | — |
| +2 | K183542 | Signature Orthodontic System | Signature Orthodontics | 2019 | — |
| +3 | K232827 | LightForce Orthodontic System | Lightforce Orthodontics | 2023 | — |
| +3 | K200148 | LightForce Orthodontic System (LFO System) | Lightforce Orthodontics | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DYW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DYW device
- #1 K252760 Carriere® Motion Pro® Clear Bite Correctorscore 10.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082207 | Orthocad IQSummary page 1…dels, Marketed by 3M Unitek Class I Exempt Product Code: LMVD (21CFR§892.2020) " OrthoCAD iQ. Marketed by Cadent, Inc. Class 11 Study model described within K082207 Product Code: DYW (Orthodontic Plastic Bracket, 21CFR§872.5470) EJF (Orthodontic Metal Bracket, 21CFR§872.5410… | 2009 |
| * | — | Lava Digital Models Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181271 | Signature Orthodontic System | 2018 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DYW devicesDYW Bracket, Plastic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DYW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYW
372in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYW
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DYW
1in 2017
MAUDE reports naming product code DYW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 2 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 3 | 372 | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123118: Insignia Digicast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123118
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026