510(k) · Cleared
ClearedUltra-Lite 200E Light Cure Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rolence Ent., Inc. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Dec 30, 2002 after a 69-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Dec 30, 2002
- Review
- 69 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK023545 Ultra-Lite 200E Light Cure UnitRolence Ent., Inc. · 2002
- Descendant · cites it directly · 4 of its ownK040618 Led TurboApoza Enterprise Co., Ltd. · 2004
- Descendant · 2 generations on · 2 of its ownK041303 Led Turbo-PenApoza Enterprise Co., Ltd. · 2004
- Descendant · 3 generations on · 0 of its ownK071722 Deep BlueE.M.S Electro Medical Systems S.A · 2007
- Descendant · 3 generations on · 0 of its ownK070373 Apoza Led Curing Light, Model E-Morlit, D-2000, Top 3W, Top 5WApoza Enterprise Co., Ltd. · 2007
- Descendant · 2 generations on · 0 of its ownK061695 Led Prolux 770Peng Lim Enterprise Co., Ltd. · 2006
Most influential descendants
Showing 5 of 5 · See all- K040618Led TurboApoza Enterprise Co., Ltd. · 2004 · cites it directly4descendants
- K041303Led Turbo-PenApoza Enterprise Co., Ltd. · 2004 · 2 generations on2descendants
- K071722Deep BlueE.M.S Electro Medical Systems S.A · 2007 · 3 generations on0descendants
- K070373Apoza Led Curing Light, Model E-Morlit, D-2000, Top 3W, Top 5WApoza Enterprise Co., Ltd. · 2007 · 3 generations on0descendants
- K061695Led Prolux 770Peng Lim Enterprise Co., Ltd. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023545 | Ultra-Lite 200E Light Cure Unit | Rolence Ent., Inc. | 2002 | — |
| +1 | K040618 | Led Turbo | Apoza Enterprise Co., Ltd. | 2004 | — |
| +2 | K041303 | Led Turbo-Pen | Apoza Enterprise Co., Ltd. | 2004 | — |
| +3 | K071722 | Deep Blue | E.M.S Electro Medical Systems S.A | 2007 | — |
| +3 | K070373 | Apoza Led Curing Light, Model E-Morlit, D-2000, Top 3W, Top 5W | Apoza Enterprise Co., Ltd. | 2007 | — |
| +2 | K061695 | Led Prolux 770 | Peng Lim Enterprise Co., Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040618 | Led Turbo | 2004 | 4 |
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, K040618 (Apoza Enterprise Co., Ltd., 2004) has gone furthest, with 4 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 ULTRA-LITE 200E IS A LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023545 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023545: Ultra-Lite 200E Light Cure Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023545
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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