510(k) · Cleared
ClearedOptilux 501
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerr Corporation (Danbury) · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Mar 21, 2002 after a 70-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Mar 21, 2002
- Review
- 70 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK020091 Optilux 501Kerr Corporation (Danbury) · 2002
- Descendant · cites it directly · 1 of its ownK033795 Plasmacure BxeEele Laboratories, LLC · 2003
- Descendant · cites it directly · 1 of its ownK033201 LA500 Blue LightApoza Enterprise Co., Ltd. · 2003
- Descendant · 2 generations on · 0 of its ownK081287 Sapphire Plasma Arc Dental Curing LightDen-Mat Holdings, LLC · 2008
- Descendant · 2 generations on · 0 of its ownK060646 Blue Luxcer Curing Light, Models M-830, M-835 and M-855Monitex Industrial Co., Ltd. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK032099 Swiss Master Light(Ems Sa) Electro Medical Systems · 2003
Most influential descendants
Showing 5 of 5 · See all- K033795Plasmacure BxeEele Laboratories, LLC · 2003 · cites it directly1descendant
- K033201LA500 Blue LightApoza Enterprise Co., Ltd. · 2003 · cites it directly1descendant
- K081287Sapphire Plasma Arc Dental Curing LightDen-Mat Holdings, LLC · 2008 · 2 generations on0descendants
- K060646Blue Luxcer Curing Light, Models M-830, M-835 and M-855Monitex Industrial Co., Ltd. · 2006 · 2 generations on0descendants
- K032099Swiss Master Light(Ems Sa) Electro Medical Systems · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020091 | Optilux 501 | Kerr Corporation (Danbury) | 2002 | — |
| +1 | K033795 | Plasmacure Bxe | Eele Laboratories, LLC | 2003 | — |
| +1 | K033201 | LA500 Blue Light | Apoza Enterprise Co., Ltd. | 2003 | — |
| +2 | K081287 | Sapphire Plasma Arc Dental Curing Light | Den-Mat Holdings, LLC | 2008 | — |
| +2 | K060646 | Blue Luxcer Curing Light, Models M-830, M-835 and M-855 | Monitex Industrial Co., Ltd. | 2006 | 1 |
| +1 | K032099 | Swiss Master Light | (Ems Sa) Electro Medical Systems | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2006 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Optilux 400 Named without a submission number |
What descends from it? (5)
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, K033795 (Eele Laboratories, LLC, 2003) has gone furthest, with 1 descendant 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 Optilux 501 is for polymerization of light cure materials and activation of dental bleaching materials
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020091: Optilux 501.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020091
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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