510(k) · Cleared
ClearedRadiance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Orthodontics · NJM Bracket, Ceramic, Orthodontic
Cleared on Aug 4, 2008 after a 140-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Aug 4, 2008
- Review
- 140 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK080749 RadianceAmerican Orthodontics · 2008
- Descendant · cites it directly · 1 of its ownK122753 Empower ClearAmerican Orthodontics · 2012
- Descendant · cites it directly · 0 of its ownK232011 CleoAmerican Orthodontics · 2023
- Descendant · cites it directly · 0 of its ownK171844 Inspire ICE aka Inspire ICE Clear BracketsOrmco Corporation · 2017
- Descendant · cites it directly · 0 of its ownK142729 Chi Lites Orthodontic Sapphire BracketProgressive Technology, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K122753Empower ClearAmerican Orthodontics · 2012 · cites it directly1descendant
- K232011CleoAmerican Orthodontics · 2023 · cites it directly0descendants
- K171844Inspire ICE aka Inspire ICE Clear BracketsOrmco Corporation · 2017 · cites it directly0descendants
- K142729Chi Lites Orthodontic Sapphire BracketProgressive Technology, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080749 | Radiance | American Orthodontics | 2008 | — |
| +1 | K122753 | Empower Clear | American Orthodontics | 2012 | — |
| +1 | K232011 | Cleo | American Orthodontics | 2023 | — |
| +1 | K171844 | Inspire ICE aka Inspire ICE Clear Brackets | Ormco Corporation | 2017 | — |
| +1 | K142729 | Chi Lites Orthodontic Sapphire Bracket | Progressive Technology, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
4 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?
- Of its descendants, K122753 (American Orthodontics, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Radiance is an orthodontic bracket. Orthodontic brackets are prescribed for patients with teeth that are not normally positioned in the mouth. An orthodontic bracket is a device consisting of a base, an arch wire slot and four tie wings. The bracket bases are attached to a patient's teeth with adhesive. A metal arch wire is placed in the arch wire slot of a set of brackets (typi.cally ten brackets on each of the upper and lower arches) and the wire is…
Read the full statement (172 words)
Radiance is an orthodontic bracket. Orthodontic brackets are prescribed for patients with teeth that are not normally positioned in the mouth. An orthodontic bracket is a device consisting of a base, an arch wire slot and four tie wings. The bracket bases are attached to a patient's teeth with adhesive. A metal arch wire is placed in the arch wire slot of a set of brackets (typi.cally ten brackets on each of the upper and lower arches) and the wire is held in place in each bracket slot with an elastic o-ring placed under the tie winfi';. and over the arch wire.
Orthodontic treatment is used to correct dental deficiencies and to improve the appearance of the patient. The brackets, arch wire and elastic o-riings form a force system that is designed to gradually move teeth into a normal alignment. Radiance brackets can enhance the patient's appearance during treatment because the bracket is highly transparent. These brackets are less visible than metal brackets and are preferred hy many patients - especially adults.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K080749 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080749: Radiance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080749
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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