510(k) · Cleared
ClearedGC E-Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Aug 7, 2001 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.
- Decided
- Aug 7, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK012134 GC E-LightGC America, Inc. · 2001
- Descendant · cites it directly · 11 of its ownK032465 Mini L.E.D., Model: Mini L.E.D., Model Smartlite MiniSatelec · 2003
- Descendant · 2 generations on · 5 of its ownK042703 Cybird Led Curing LightDxm Co., Ltd. · 2004
- Descendant · 3 generations on · 3 of its ownK121093 D1 Led Curing Light, Spec 3, Dentronix Led 3000Dxm Co., Ltd. · 2012
- Descendant · 4 generations on · 1 of its ownK173876 Cybird LED Curing LightDxm Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK072181 Mini Led AutofocusSatelec · 2007
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K032465Mini L.E.D., Model: Mini L.E.D., Model Smartlite MiniSatelec · 2003 · cites it directly11descendants
- K042703Cybird Led Curing LightDxm Co., Ltd. · 2004 · 2 generations on5descendants
- K121093D1 Led Curing Light, Spec 3, Dentronix Led 3000Dxm Co., Ltd. · 2012 · 3 generations on3descendants
- K173876Cybird LED Curing LightDxm Co., Ltd. · 2018 · 4 generations on1descendant
- K072181Mini Led AutofocusSatelec · 2007 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012134 | GC E-Light | GC America, Inc. | 2001 | — |
| +1 | K032465 | Mini L.E.D., Model: Mini L.E.D., Model Smartlite Mini | Satelec | 2003 | — |
| +2 | K042703 | Cybird Led Curing Light | Dxm Co., Ltd. | 2004 | — |
| +3 | K121093 | D1 Led Curing Light, Spec 3, Dentronix Led 3000 | Dxm Co., Ltd. | 2012 | — |
| +4 | K173876 | Cybird LED Curing Light | Dxm Co., Ltd. | 2018 | — |
| +2 | K072181 | Mini Led Autofocus | Satelec | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 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? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032465 | Mini L.E.D., Model: Mini L.E.D., Model Smartlite Mini | 2003 | 11 |
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, K032465 (Satelec, 2003) has gone furthest, with 11 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?
Source of illumination for curing visible light cured dental materials such as composites, bonding agents and glass ionomer cements.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012134: GC E-Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012134
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026