510(k) · Cleared
ClearedInsignia
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 Aug 9, 2012 as substantially equivalent to K082207 (Cadent, Inc., 2009) after a 78-day review. Its family tree reaches back 1 generation to 2009. 3 later devices descend from it.
- Decided
- Aug 9, 2012
- Review
- 78 days
- Class
- Class II
- Product code
- DYW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082207 (2009). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK082207 Orthocad IQCadent, Inc. · 2009
- This deviceK121524 InsigniaOrmco Corp. · 2012
- Descendant · cites it directly · 1 of its ownK203442 Inbrace Orthodontic SystemSwift Health Systems, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK253343 Celebrace SoftwareCelebrace · 2025
- Descendant · cites it directly · 0 of its ownK123416 Insignia with IteroOrmco Corp. · 2013
Most influential descendants
Showing 3 of 3 · See allView 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) | K121524 | Insignia | Ormco Corp. | 2012 | — |
| +1 | K203442 | Inbrace Orthodontic System | Swift Health Systems, Inc. | 2021 | — |
| +2 | K253343 | Celebrace Software | Celebrace | 2025 | — |
| +1 | K123416 | Insignia with Itero | Ormco Corp. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (1)
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…W), Orthodontic Ceramic Bracket (NJM) and Orthodontic Metal Bracket (EJF) Devices for Which Substantial Equivalence isClaimed * OrthoCAD 10, Cadent, Inc., K(082207 Device Description: Principles of Operation The Insignia software creates a computer model of the patient's… | 2009 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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. 2012, 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?
The Insignia Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121524: Insignia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121524
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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