510(k) · Cleared
ClearedSignature Orthodontic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signature Orthodontics · NJM Bracket, Ceramic, Orthodontic
Cleared on Jun 13, 2018 as substantially equivalent to K160615 (Tomy, Inc., 2016) and 1 other predicate after a 30-day review. Its family tree reaches back 5 generations to 1985. 4 later devices descend from it.
- Decided
- Jun 13, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K852179 (1985). 12 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
- 4 generations backK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
- 3 generations backK082974 Mystique MB Ceramic BracketsDentsply Interntional · 2008
- 2 generations backK102803 Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011
- 1 generation backK160615 Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016
- This deviceK181271 Signature Orthodontic SystemSignature Orthodontics · 2018
- Descendant · cites it directly · 1 of its ownK222764 LightForce Orthodontic SystemLightforce Orthodontics · 2022
- Descendant · cites it directly · 1 of its ownK183542 Signature Orthodontic SystemSignature Orthodontics · 2019
- Descendant · 2 generations on · 0 of its ownK232827 LightForce Orthodontic SystemLightforce Orthodontics · 2023
- Descendant · 2 generations on · 0 of its ownK200148 LightForce Orthodontic System (LFO System)Lightforce Orthodontics · 2020
Most influential descendants
Showing 4 of 4 · See all- K222764LightForce Orthodontic SystemLightforce Orthodontics · 2022 · cites it directly1descendant
- K183542Signature Orthodontic SystemSignature Orthodontics · 2019 · cites it directly1descendant
- K232827LightForce Orthodontic SystemLightforce Orthodontics · 2023 · 2 generations on0descendants
- K200148LightForce Orthodontic System (LFO System)Lightforce Orthodontics · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K852179 | Ceramic Orthodonit Appliance | Gac Intl., Inc. | 1985 | — |
| −4 | K042178 | Orthodontic Ceramic Brackets | Dentsply Intl. | 2004 | — |
| −3 | K082974 | Mystique MB Ceramic Brackets | Dentsply Interntional | 2008 | — |
| −2 | K102803 | Clarity Advanced Ceramic Brackets | 3M Unitek Corporation | 2011 | — |
| −1 | K160615 | Orthodontic Ceramic Brackets 1.1 | Tomy, Inc. | 2016 | — |
| 0 (this device) | K181271 | Signature Orthodontic System | Signature Orthodontics | 2018 | — |
| +1 | K222764 | LightForce Orthodontic System | Lightforce Orthodontics | 2022 | — |
| +1 | K183542 | Signature Orthodontic System | Signature Orthodontics | 2019 | — |
| +2 | K232827 | LightForce Orthodontic System | Lightforce Orthodontics | 2023 | — |
| +2 | K200148 | LightForce Orthodontic System (LFO System) | Lightforce Orthodontics | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 NJM? 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 NJM device
- #1 K222764 LightForce Orthodontic Systemscore 8.5 · 6 generations · 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 |
|---|---|---|---|
| * | K160615 | Orthodontic Ceramic Brackets 1.1Summary page 4…thodontic Ceramic Bracket, 21CFR§872.5470 Regulatory Class: II Product Code: NJM Predicate Devices: Primary Predicate: TOMY Orthodontic Ceramic Brackets 1.1 (K160615) Reference Predicate: Insignia Digicast (K123118) Signature Orthodontics June 13, 2018… | 2016 |
| * | K123118 | Insignia DigicastSummary page 4…s: II Product Code: NJM Predicate Devices: Primary Predicate: TOMY Orthodontic Ceramic Brackets 1.1 (K160615) Reference Predicate: Insignia Digicast (K123118) Signature Orthodontics June 13, 2018 Page 6-1 Traditional 5… | 2013 |
What descends from it? (4)
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?
- The line of descent spans 33 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K222764 (Lightforce Orthodontics, 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K160615.
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NJM
5in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NJM
1in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NJM
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NJM
1in 2025
MAUDE reports naming product code NJM, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 134 | 0 | 0 |
| 2009 | 4 | 61 | 0 | 1 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 4 | 122 | 0 | 1 |
| 2012 | 6 | 90 | 0 | 1 |
| 2013 | 3 | 123 | 1 | 6 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 3 | 234 | 0 | 0 |
| 2016 | 3 | 176 | 0 | 2 |
| 2017 | 3 | 183 | 0 | 2 |
| 2018 | 4 | 76 | 0 | 2 |
| 2019 | 6 | 200 | 0 | 0 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 5 | 1 | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Signature Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181271 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181271: Signature Orthodontic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181271
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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