510(k) · Cleared
ClearedVALO X, VALO X Accessory Lenses
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 Feb 22, 2022 as substantially equivalent to K210550 (Ultradent Products, Inc., 2021) after a 4-day review. Its family tree reaches back 7 generations to 2001. 2 later devices descend from it.
- Decided
- Feb 22, 2022
- Review
- 4 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K003995 (2001). 14 ancestors in all, the oldest K003383 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK003995 Speculite/OralliteTrylon Corp. · 2001
- 6 generations backK060920 VelscopeLed Medical Diagnostics, Inc. · 2006
- 5 generations backK070523 Modification to: VelscopeLed Dental, Inc. · 2007
- 4 generations backK082603 Trimira Ocs 3000Remicalm, LLC · 2008
- 3 generations backK090135 Trimira Identafi 3000Remicalm, LLC · 2009
- 2 generations backK101140 Dentlight Oral Exam Light KitDentlight, Inc. · 2010
- 1 generation backK210550 VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021
- This deviceK220471 VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK253461 Demi ProMeta Systems Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243921 LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd. · 2025
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 |
|---|---|---|---|---|---|
| −7 | K003995 | Speculite/Orallite | Trylon Corp. | 2001 | — |
| −6 | K060920 | Velscope | Led Medical Diagnostics, Inc. | 2006 | — |
| −5 | K070523 | Modification to: Velscope | Led Dental, Inc. | 2007 | — |
| −4 | K082603 | Trimira Ocs 3000 | Remicalm, LLC | 2008 | — |
| −3 | K090135 | Trimira Identafi 3000 | Remicalm, LLC | 2009 | — |
| −2 | K101140 | Dentlight Oral Exam Light Kit | Dentlight, Inc. | 2010 | — |
| −1 | K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | 2021 | — |
| 0 (this device) | K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | 2022 | — |
| +1 | K253461 | Demi Pro | Meta Systems Co., Ltd. | 2025 | — |
| +1 | 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 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K210550 | VALO Grand Corded and Accessory LensesSummary page 5…nses are not intended for complete cure of photo-activated materials and adhesives. V. Predicate Device VALO X and VALO X Accessory Lenses identified predicate device: K210550 – VALO™ Grand Corded and Accessory Lenses by Ultradent Products. VI. Comparison of Technological Characteristics Predicate tech… | 2021 |
| † | K190627 | VALO Grand Corded | 2019 |
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 21 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K253461 (Meta Systems Co., Ltd., 2025) has gone furthest, with 0 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. 2022, 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?
VALO X curing light is a source of illumination for curing photo-activated dental restorative materials and adhesives. It is also intended to provide illumination to aid in visualization during oral procedures. VALO X curing light accessory/diffusor lenses are not intended for complete cure of photo-activated materials and adhesives.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220471 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220471: VALO X, VALO X Accessory Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220471
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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