510(k) · Cleared
ClearedColtolux Led Curing Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coltene/Whaledent, Inc. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Mar 15, 2004 after a 13-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Mar 15, 2004
- Review
- 13 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK040551 Coltolux Led Curing LightColtene/Whaledent, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK121093 D1 Led Curing Light, Spec 3, Dentronix Led 3000Dxm Co., Ltd. · 2012
- Descendant · 2 generations on · 1 of its ownK173876 Cybird LED Curing LightDxm Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK153514 Premium Plus C01/C02 LED Curing LightPremium Plus International Limited · 2016
- Descendant · 2 generations on · 0 of its ownK250009 LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) Limited · 2025
- Descendant · cites it directly · 0 of its ownK223142 Coltolux Comfort LED Curing LightDent4you AG · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K121093D1 Led Curing Light, Spec 3, Dentronix Led 3000Dxm Co., Ltd. · 2012 · cites it directly3descendants
- K173876Cybird LED Curing LightDxm Co., Ltd. · 2018 · 2 generations on1descendant
- K153514Premium Plus C01/C02 LED Curing LightPremium Plus International Limited · 2016 · cites it directly1descendant
- K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) Limited · 2025 · 2 generations on0descendants
- K223142Coltolux Comfort LED Curing LightDent4you AG · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040551 | Coltolux Led Curing Light | Coltene/Whaledent, Inc. | 2004 | — |
| +1 | K121093 | D1 Led Curing Light, Spec 3, Dentronix Led 3000 | Dxm Co., Ltd. | 2012 | — |
| +2 | K173876 | Cybird LED Curing Light | Dxm Co., Ltd. | 2018 | — |
| +1 | K153514 | Premium Plus C01/C02 LED Curing Light | Premium Plus International Limited | 2016 | — |
| +2 | K250009 | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited | 2025 | — |
| +1 | K223142 | Coltolux Comfort LED Curing Light | Dent4you AG | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
3 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, K121093 (Dxm Co., Ltd., 2012) has gone furthest, with 3 descendants of its own.
How does its category compare?
All EBZ devicesEBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
This device is indicated for the polymerization of intra oral and extra oral restorations fabricated from materials [commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives ] that contain Camphorquinone as the photo initiator.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040551: Coltolux Led Curing Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040551
Report an extraction error
Are you the manufacturer?
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