510(k) · Cleared
ClearedLED Curing Lights (DB686 HALO)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Coxo Medical Instrument Co., Ltd. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Apr 11, 2025 as substantially equivalent to K220826 (Foshan Coxo Medical Instrument Co., Ltd., 2022) and 1 other predicate after a 112-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Apr 11, 2025
- Review
- 112 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K003995 (2001). 20 ancestors in all, the oldest K003383 (2001). No later device cites it as a predicate yet.
- Root · 8 generations backK003995 Speculite/OralliteTrylon Corp. · 2001
- 7 generations backK060920 VelscopeLed Medical Diagnostics, Inc. · 2006
- 6 generations backK070523 Modification to: VelscopeLed Dental, Inc. · 2007
- 5 generations backK082603 Trimira Ocs 3000Remicalm, LLC · 2008
- 4 generations backK090135 Trimira Identafi 3000Remicalm, LLC · 2009
- 3 generations backK101140 Dentlight Oral Exam Light KitDentlight, Inc. · 2010
- 2 generations backK210550 VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021
- 1 generation backK220471 VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022
- This deviceK243921 LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003995 | Speculite/Orallite | Trylon Corp. | 2001 | — |
| −7 | K060920 | Velscope | Led Medical Diagnostics, Inc. | 2006 | — |
| −6 | K070523 | Modification to: Velscope | Led Dental, Inc. | 2007 | — |
| −5 | K082603 | Trimira Ocs 3000 | Remicalm, LLC | 2008 | — |
| −4 | K090135 | Trimira Identafi 3000 | Remicalm, LLC | 2009 | — |
| −3 | K101140 | Dentlight Oral Exam Light Kit | Dentlight, Inc. | 2010 | — |
| −2 | K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | 2021 | — |
| −1 | K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | 2022 | — |
| 0 (this device) | K243921 | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K220826 | LED Curing LightSummary page 5…umber: 21 CFR Part 872.6070 Product Code(s): EBZ, EAQ Submission Type: Traditional 510(K) 3. Legally Marketed Predicate Devices Primary Predicate Device 510(k) Number: K220826 Product Name: LED Curing Light (Model: DB686 NANO, DB686 SWIFT) 1 === Page 6 ==… | 2022 |
| * | K220471 | VALO X, VALO X Accessory LensesSummary page 6…g Light (Model: DB686 NANO, DB686 SWIFT) 1 Product Code: EBZ Secondary Predicate Device 510(k) Number: K220471 Product Name: VALO™ X; VALO™ X Accessory Lenses Product Code: EBZ, EAQ, PEQ Reference Device 1# 510(k) Number: K221194 Product… | 2022 |
| † | K221194 | LEDEX | 2022 |
| † | K221152 | CuringPen Dental Curing Light | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- None of the 20 ancestors has a recall.
- 1 other device also cites its predicate K220826.
How does its category compare?
All EBZ devicesEBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
For dental clinics treatment to irradiate polymer-based restorative materials to cure them.
The instrument must only be used in hospital environments, clinics or dental offices, by qualified practitioners.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243921: LED Curing Lights (DB686 HALO).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243921
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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