510(k) · Cleared
ClearedMini L.E.D., Model: Mini L.E.D., Model Smartlite Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Oct 21, 2003 as substantially equivalent to K961735 (Satelec, 1996) and 2 other predicates after a 71-day review. Its family tree reaches back 1 generation to 1996. 11 later devices descend from it.
- Decided
- Oct 21, 2003
- Review
- 71 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K961735 (1996). 3 ancestors in all. 11 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK961735 ACTASatelec · 1996
- This deviceK032465 Mini L.E.D., Model: Mini L.E.D., Model Smartlite MiniSatelec · 2003
- Descendant · cites it directly · 5 of its ownK042703 Cybird Led Curing LightDxm Co., Ltd. · 2004
- Descendant · 2 generations on · 3 of its ownK121093 D1 Led Curing Light, Spec 3, Dentronix Led 3000Dxm Co., Ltd. · 2012
- Descendant · 3 generations on · 1 of its ownK173876 Cybird LED Curing LightDxm Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK072181 Mini Led AutofocusSatelec · 2007
- Descendant · 4 generations on · 0 of its ownK191221 Cybird LED Curing LightDxm Co., Ltd. · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K042703Cybird Led Curing LightDxm Co., Ltd. · 2004 · cites it directly5descendants
- K121093D1 Led Curing Light, Spec 3, Dentronix Led 3000Dxm Co., Ltd. · 2012 · 2 generations on3descendants
- K173876Cybird LED Curing LightDxm Co., Ltd. · 2018 · 3 generations on1descendant
- K072181Mini Led AutofocusSatelec · 2007 · cites it directly1descendant
- K191221Cybird LED Curing LightDxm Co., Ltd. · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961735 | ACTA | Satelec | 1996 | — |
| 0 (this device) | 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 | — |
| +2 | K121093 | D1 Led Curing Light, Spec 3, Dentronix Led 3000 | Dxm Co., Ltd. | 2012 | — |
| +3 | K173876 | Cybird LED Curing Light | Dxm Co., Ltd. | 2018 | — |
| +1 | K072181 | Mini Led Autofocus | Satelec | 2007 | — |
| +4 | K191221 | Cybird LED Curing Light | Dxm Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 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 |
|---|---|---|---|
| * | K961735 | ACTASummary page 1…The Mini L.E.D. is substantially equivalent to the following previously cleared and currently marketing devices: Satelec ACTA (K961735) 3M ESPE Epilar Freelight (KO1 1154) GC America GC E-Light (K012134) i D… | 1996 |
| * | K011154 | Elipar Freelight | 2001 |
| * | K012134 | GC E-LightSummary page 1…eting devices: Satelec ACTA (K961735) 3M ESPE Epilar Freelight (KO1 1154) GC America GC E-Light (K012134) i D. Device Descridion and Intended Use The Satelec Mini L.E.D. product is classified as an Ultraviolet Activa… | 2001 |
What descends from it? (11)
See all 115 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?
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?
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental materials,
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) restorative composite materials, and
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) orthodontic brackets, and orthodontic bonding and sealing materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032465 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032465: Mini L.E.D., Model: Mini L.E.D., Model Smartlite Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032465
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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