510(k) · Cleared
ClearedLed Turbo-Pen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apoza Enterprise Co., Ltd. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Jun 18, 2004 as substantially equivalent to K040618 (Apoza Enterprise Co., Ltd., 2004) after a 32-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it.
- Decided
- Jun 18, 2004
- Review
- 32 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K023545 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK023545 Ultra-Lite 200E Light Cure UnitRolence Ent., Inc. · 2002
- 1 generation backK040618 Led TurboApoza Enterprise Co., Ltd. · 2004
- This deviceK041303 Led Turbo-PenApoza Enterprise Co., Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK071722 Deep BlueE.M.S Electro Medical Systems S.A · 2007
- Descendant · cites it directly · 0 of its ownK070373 Apoza Led Curing Light, Model E-Morlit, D-2000, Top 3W, Top 5WApoza Enterprise Co., Ltd. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023545 | Ultra-Lite 200E Light Cure Unit | Rolence Ent., Inc. | 2002 | — |
| −1 | K040618 | Led Turbo | Apoza Enterprise Co., Ltd. | 2004 | — |
| 0 (this device) | K041303 | Led Turbo-Pen | Apoza Enterprise Co., Ltd. | 2004 | — |
| +1 | K071722 | Deep Blue | E.M.S Electro Medical Systems S.A | 2007 | — |
| +1 | K070373 | Apoza Led Curing Light, Model E-Morlit, D-2000, Top 3W, Top 5W | Apoza Enterprise Co., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 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 |
|---|---|---|---|
| * | K040618 | Led TurboSummary page 1…polymerization PLUS. TOP Light Turbo) 8.10 Legally market device equivalence: Device name: Led Turbo 51 Ok number: K040618 Manufacturer: APOZA Enterprise, Co,.Ltd. 8.11 Intended use: The LED Turbo-Pen is a dental curing light… | 2004 |
What descends from it? (2)
2 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?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K071722 (E.M.S Electro Medical Systems S.A, 2007) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K040618.
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 LED Turbo-Pen is a dental curing light that is designed for use in the optical polymerization of dental resins.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041303 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041303: Led Turbo-Pen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041303
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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