510(k) · Cleared
ClearedD1 Led Curing Light, Spec 3, Dentronix Led 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dxm Co., Ltd. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Nov 27, 2012 as substantially equivalent to K042703 (Dxm Co., Ltd., 2004) and 2 other predicates after a 231-day review. Its family tree reaches back 3 generations to 1996. 3 later devices descend from it.
- Decided
- Nov 27, 2012
- Review
- 231 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K961735 (1996). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK961735 ACTASatelec · 1996
- 2 generations backK032465 Mini L.E.D., Model: Mini L.E.D., Model Smartlite MiniSatelec · 2003
- 1 generation backK042703 Cybird Led Curing LightDxm Co., Ltd. · 2004
- This deviceK121093 D1 Led Curing Light, Spec 3, Dentronix Led 3000Dxm Co., Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK173876 Cybird LED Curing LightDxm Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK191221 Cybird LED Curing LightDxm Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK140281 Flexi-Lume Led SystemEpic Medical Concepts & Innovations · 2014
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 |
|---|---|---|---|---|---|
| −3 | K961735 | ACTA | Satelec | 1996 | — |
| −2 | K032465 | Mini L.E.D., Model: Mini L.E.D., Model Smartlite Mini | Satelec | 2003 | — |
| −1 | K042703 | Cybird Led Curing Light | Dxm Co., Ltd. | 2004 | — |
| 0 (this device) | K121093 | D1 Led Curing Light, Spec 3, Dentronix Led 3000 | Dxm Co., Ltd. | 2012 | — |
| +1 | K173876 | Cybird LED Curing Light | Dxm Co., Ltd. | 2018 | — |
| +2 | K191221 | Cybird LED Curing Light | Dxm Co., Ltd. | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K042703 | Cybird Led Curing LightSummary page 2…== The D1 LED Curing Light is substantially equivalent to: dxm a Cybird LED curing light (K042703) * Coltolux LED (K040551) e Valo Cordless (K110582) 4. Device Description: D1 by DXM Co., Ltd. is clas… | 2004 |
| * | K040551 | Coltolux Led Curing LightSummary page 2…s substantially equivalent to: dxm a Cybird LED curing light (K042703) * Coltolux LED (K040551) e Valo Cordless (K110582) 4. Device Description: D1 by DXM Co., Ltd. is classified as an Ultraviolet Activato… | 2004 |
| * | K110582 | Valo CordlessSummary page 2…dxm a Cybird LED curing light (K042703) * Coltolux LED (K040551) e Valo Cordless (K110582) 4. Device Description: D1 by DXM Co., Ltd. is classified as an Ultraviolet Activator for polymerization (21 CFR… | 2011 |
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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K173876 (Dxm Co., Ltd., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K042703.
How does its category compare?
All EBZ devicesEBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 D1 LED Curing Light & accessories is intended to polymerize resinous dental materials, restorative composite materials, orthodontic brackets bonding and sealing materials that are photo-polymerized in the 430-490nm waveband of visible light.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121093: D1 Led Curing Light, Spec 3, Dentronix Led 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121093
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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