510(k) · Cleared
ClearedTruklear Bracket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ajw Technology Consultants, Inc. · NJM Bracket, Ceramic, Orthodontic
Cleared on Jun 25, 2014 as substantially equivalent to K090933 (Forestadent Bernhard Forster GmbH, 2009) after a 57-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Jun 25, 2014
- Review
- 57 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K852179 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
- 3 generations backK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
- 2 generations backK060837 IN-Ovation CDentsply International · 2006
- 1 generation backK090933 Bernhard-Forster GMBH Orthodontic Ceramic BracketsForestadent Bernhard Forster GmbH · 2009
- This deviceK141104 Truklear BracketAjw Technology Consultants, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852179 | Ceramic Orthodonit Appliance | Gac Intl., Inc. | 1985 | — |
| −3 | K042178 | Orthodontic Ceramic Brackets | Dentsply Intl. | 2004 | — |
| −2 | K060837 | IN-Ovation C | Dentsply International | 2006 | — |
| −1 | K090933 | Bernhard-Forster GMBH Orthodontic Ceramic Brackets | Forestadent Bernhard Forster GmbH | 2009 | — |
| 0 (this device) | K141104 | Truklear Bracket | Ajw Technology Consultants, Inc. | 2014 | — |
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? (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 |
|---|---|---|---|
| * | K090933 | Bernhard-Forster GMBH Orthodontic Ceramic BracketsSummary page 2…Equivalence: The Orthodontic Ceramic Brackets are substantial equivalent in intended use and similar technological characteristics to the: Orthodontic Ceramic Brackets (K090933) for the orthodontic movement of teeth to alter tooth position. 'Applicant For6stadent Bernhard-'-,… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K090933.
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141104 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141104: Truklear Bracket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141104
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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