510(k) · Cleared
ClearedValo Cordless
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultradent Products, Inc. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Apr 28, 2011 as substantially equivalent to K083647 (Ultradent Products, Inc., 2009) after a 58-day review. Its family tree reaches back 2 generations to 2001. 11 later devices descend from it.
- Decided
- Apr 28, 2011
- Review
- 58 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003383 (2001). 11 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK003383 PalmlightUltradent Products, Inc. · 2001
- 1 generation backK083647 Valo, Model 5919Ultradent Products, Inc. · 2009
- This deviceK110582 Valo CordlessUltradent Products, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK121093 D1 Led Curing Light, Spec 3, Dentronix Led 3000Dxm Co., Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK200775 LOOP LED Curing Light SystemGarrison Dental Solutions, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK173876 Cybird LED Curing LightDxm Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK160551 VALO GrandUltradent Products, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK241238 LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K121093D1 Led Curing Light, Spec 3, Dentronix Led 3000Dxm Co., Ltd. · 2012 · cites it directly3descendants
- K200775LOOP LED Curing Light SystemGarrison Dental Solutions, LLC · 2020 · cites it directly1descendant
- K173876Cybird LED Curing LightDxm Co., Ltd. · 2018 · 2 generations on1descendant
- K160551VALO GrandUltradent Products, Inc. · 2016 · cites it directly1descendant
- K241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003383 | Palmlight | Ultradent Products, Inc. | 2001 | — |
| −1 | K083647 | Valo, Model 5919 | Ultradent Products, Inc. | 2009 | — |
| 0 (this device) | K110582 | Valo Cordless | Ultradent Products, Inc. | 2011 | — |
| +1 | K121093 | D1 Led Curing Light, Spec 3, Dentronix Led 3000 | Dxm Co., Ltd. | 2012 | — |
| +1 | K200775 | LOOP LED Curing Light System | Garrison Dental Solutions, LLC | 2020 | — |
| +2 | K173876 | Cybird LED Curing Light | Dxm Co., Ltd. | 2018 | — |
| +1 | K160551 | VALO Grand | Ultradent Products, Inc. | 2016 | — |
| +2 | K241238 | LOOP™ LED Curing Light System (CLK01) | Garrison Dental Solutions, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K083647 | Valo, Model 5919Summary page 1…ion: 11 Classification Product Code: EBZ Legally Marketed Predicate Device to Which Equivalence is Claimed The predicate device is VALOI (K(083647). This device is manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, Utah 84095. Pro… | 2009 |
What descends from it? (11)
See all 116 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 10 years and passes through 1 company; a new generation was cleared every 8.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K121093 (Dxm Co., Ltd., 2012) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K083647.
How does its category compare?
All EBZ devicesEBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Source of illumination for curing photo-activated dental restorative materials and adhesives.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110582: Valo Cordless.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110582
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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