510(k) · Cleared
ClearedMini Led Autofocus
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 Sep 19, 2007 as substantially equivalent to K032465 (Satelec, 2003) after a 44-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Sep 19, 2007
- Review
- 44 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961735 (1996). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK961735 ACTASatelec · 1996
- 1 generation backK032465 Mini L.E.D., Model: Mini L.E.D., Model Smartlite MiniSatelec · 2003
- This deviceK072181 Mini Led AutofocusSatelec · 2007
- Descendant · cites it directly · 0 of its ownK131906 Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray…Satelec - Acteon Group · 2014
Most influential descendants
Showing 1 of 1 · See all- K131906Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray Cord), Scanwave Pen…Satelec - Acteon Group · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961735 | ACTA | Satelec | 1996 | — |
| −1 | K032465 | Mini L.E.D., Model: Mini L.E.D., Model Smartlite Mini | Satelec | 2003 | — |
| 0 (this device) | K072181 | Mini Led Autofocus | Satelec | 2007 | — |
| +1 | K131906 | Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray Cord)… | Satelec - Acteon Group | 2014 | — |
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 |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K032465 | Mini L.E.D., Model: Mini L.E.D., Model Smartlite MiniSummary page 1…of Predicate Device Device Applicant 510(k) No. Date Cleared Mini LED and Satelec K032465 Oct. 21, 2003 Smartlite Mini The Satelec Mini LED AutoFocus is substantially equivalent to the pred… | 2003 |
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 |
|---|---|---|---|
| K131906 | Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray Cord), Scanwave Pen… | 2014 | 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?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 7.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K131906 (Satelec - Acteon Group, 2014) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K032465.
How does its category compare?
All EBZ devicesEBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Satelec Mini LED AutoFocus is intended to be used by qualified dental practitioners as an ultraviolet activator for polymerization for:
photo-polymerization in the 420-480 nm waveband of visible light cured (VLC) dental materials
photo-polymerization in the 420-480 nm waveband of visible light cured (VLC) restorative composite materials, and
photo-polymerization in the 420-480 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/K072181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072181: Mini Led Autofocus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072181
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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