510(k) · Cleared
ClearedPlasmacure Bxe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eele Laboratories, LLC · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Dec 19, 2003 as substantially equivalent to K024374 (Lokki Lasers Medicaux, 2003) and 2 other predicates after a 14-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Dec 19, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K001719 (2000). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K081287Sapphire Plasma Arc Dental Curing LightDen-Mat Holdings, LLC · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001719 | Q-Lux Plasma 100 Light Cure Unit | Rolence Enterprise Co., Ltd. | 2000 | — |
| 0 (this device) | K033795 | Plasmacure Bxe | Eele Laboratories, LLC | 2003 | — |
| +1 | K081287 | Sapphire Plasma Arc Dental Curing Light | Den-Mat Holdings, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K024374 | Rmo Plasma Curing LightSummary page 2…Reg. # Name Classification Applicant No. Code Name Rmo Plasma Activator, Lokki Lasers K024374 EBZ 872.6070 Curing Light Ultraviolet, for Medicaux Polymerization Q-Lux Plasma Ac… | 2003 |
| * | K001719 | Q-Lux Plasma 100 Light Cure UnitSummary page 2…74 EBZ 872.6070 Curing Light Ultraviolet, for Medicaux Polymerization Q-Lux Plasma Activator, Rolence Enterprise K001719 EBZ 872.6070 100 Light Cure Ultraviolet, for Co., LTD Unit Polymerization Optilux 501 A… | 2000 |
| * | K020091 | Optilux 501Summary page 2…9 EBZ 872.6070 100 Light Cure Ultraviolet, for Co., LTD Unit Polymerization Optilux 501 Activator, Kerr Corporation K020091 EBZ 872.6070 Ultraviolet, for (Danbury) Polymerization Device Descriptio… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081287 | Sapphire Plasma Arc Dental Curing Light | 2008 | 0 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K081287 (Den-Mat Holdings, LLC, 2008) has gone furthest, with 0 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?
The PlasmaCure BXe Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033795 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033795: Plasmacure Bxe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033795
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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