510(k) · Cleared
ClearedValo, Model 5919
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 Jan 23, 2009 as substantially equivalent to K003383 (Ultradent Products, Inc., 2001) after a 45-day review. Its family tree reaches back 1 generation to 2001. 17 later devices descend from it.
- Decided
- Jan 23, 2009
- Review
- 45 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003383 (2001). 17 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK003383 PalmlightUltradent Products, Inc. · 2001
- This deviceK083647 Valo, Model 5919Ultradent Products, Inc. · 2009
- Descendant · cites it directly · 11 of its ownK110582 Valo CordlessUltradent Products, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK190627 VALO Grand CordedUltradent Products, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK210550 VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK121093 D1 Led Curing Light, Spec 3, Dentronix Led 3000Dxm Co., Ltd. · 2012
- Descendant · 3 generations on · 2 of its ownK220471 VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K110582Valo CordlessUltradent Products, Inc. · 2011 · cites it directly11descendants
- K190627VALO Grand CordedUltradent Products, Inc. · 2019 · cites it directly4descendants
- K210550VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021 · 2 generations on3descendants
- K121093D1 Led Curing Light, Spec 3, Dentronix Led 3000Dxm Co., Ltd. · 2012 · 2 generations on3descendants
- K220471VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003383 | Palmlight | Ultradent Products, Inc. | 2001 | — |
| 0 (this device) | K083647 | Valo, Model 5919 | Ultradent Products, Inc. | 2009 | — |
| +1 | K110582 | Valo Cordless | Ultradent Products, Inc. | 2011 | — |
| +1 | K190627 | VALO Grand Corded | Ultradent Products, Inc. | 2019 | — |
| +2 | K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | 2021 | — |
| +2 | K121093 | D1 Led Curing Light, Spec 3, Dentronix Led 3000 | Dxm Co., Ltd. | 2012 | — |
| +3 | K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K003383 | PalmlightSummary page 1…Classification Product Code EBZ Legally Marketed Predicate Device to Which Equivalence isClaimed The predicate device isPalmrlight (K003383) This device ismanufactured and distributed by Ultradent Products, Inc, 505 West, 10200 South, South Jordan, Utah 84095… | 2001 |
What descends from it? (17)
See all 172 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?
- Its one ancestor has no recall.
- Of its descendants, K110582 (Ultradent Products, Inc., 2011) 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. 2009, 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/K083647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083647: Valo, Model 5919.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083647
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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