510(k) · Cleared
ClearedFlexi-Lume Led System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epic Medical Concepts & Innovations · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Jul 24, 2014 as substantially equivalent to K121093 (Dxm Co., Ltd., 2012) after a 170-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Jul 24, 2014
- Review
- 170 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K961735 (1996). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK961735 ACTASatelec · 1996
- 3 generations backK032465 Mini L.E.D., Model: Mini L.E.D., Model Smartlite MiniSatelec · 2003
- 2 generations backK042703 Cybird Led Curing LightDxm Co., Ltd. · 2004
- 1 generation backK121093 D1 Led Curing Light, Spec 3, Dentronix Led 3000Dxm Co., Ltd. · 2012
- This deviceK140281 Flexi-Lume Led SystemEpic Medical Concepts & Innovations · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961735 | ACTA | Satelec | 1996 | — |
| −3 | K032465 | Mini L.E.D., Model: Mini L.E.D., Model Smartlite Mini | Satelec | 2003 | — |
| −2 | K042703 | Cybird Led Curing Light | Dxm Co., Ltd. | 2004 | — |
| −1 | K121093 | D1 Led Curing Light, Spec 3, Dentronix Led 3000 | Dxm Co., Ltd. | 2012 | — |
| 0 (this device) | K140281 | Flexi-Lume Led System | Epic Medical Concepts & Innovations | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 EBZ? 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 EBZ device
- #1 K253131 Curing Light (M-Cure 6)score 12.7 · 5 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 |
|---|---|---|---|
| * | K121093 | D1 Led Curing Light, Spec 3, Dentronix Led 3000Summary page 1…System Common Name: Flexi-Lume Classification: 21 CFR 872.7060 Class 11Activator, Ultraviolet, for Polymerization Product code: EBZ Predicate Device: K121093: D1 LED Curing Light Device Description: The Flexi-Lume LED System is classified as an Ultraviolet Activator for Polymerization… | 2012 |
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 18 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K121093.
How does its category compare?
All EBZ devicesEBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · EBZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBZ
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBZ
1in 2025
MAUDE reports naming product code EBZ, 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 | 10 | 47 | 0 | 1 |
| 2008 | 5 | 75 | 0 | 7 |
| 2009 | 4 | 69 | 0 | 5 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 3 | 137 | 0 | 18 |
| 2012 | 1 | — | 1 | 20 |
| 2013 | 3 | 171 | 0 | 27 |
| 2014 | 3 | 289 | 0 | 31 |
| 2015 | 4 | 252 | 0 | 8 |
| 2016 | 4 | 251 | 0 | 3 |
| 2017 | 8 | 158 | 0 | 5 |
| 2018 | 2 | — | 1 | 3 |
| 2019 | 5 | 145 | 0 | 0 |
| 2020 | 5 | 164 | 0 | 2 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 5 | 144 | 1 | 5 |
| 2023 | 3 | 255 | 0 | 7 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 4 | 105 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Flexi-Lume LED System is intended to polymerize dental materials, restorative composite materials, orthodontic brackets bonding and sealing materials that are photo-polymerized in the 430-490nm waveband of visible light. It is also intended to illuminate the patient's oral structures. It is also intended for bleaching procedures to apply light to a tooth after it is treated with a bleaching agent.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140281: Flexi-Lume Led System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140281
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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