510(k) · Cleared
ClearedNova Cordless Curing Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova/Da Vinci Systems, Inc. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Mar 27, 2000 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Mar 27, 2000
- Review
- 49 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK000393 Nova Cordless Curing LightNova/Da Vinci Systems, Inc. · 2000
- Descendant · cites it directly · 13 of its ownK031615 Sled Curing Light SystemDentsply International · 2003
- Descendant · 2 generations on · 12 of its ownK041372 Smartlite PS Pen-Style Led Curing LightDentsply International · 2004
- Descendant · 3 generations on · 7 of its ownK063529 Pencure, Model VL-7J. Morita USA, Inc. · 2007
- Descendant · 4 generations on · 6 of its ownK071190 Root ZX IIJ. Morita USA, Inc. · 2007
- Descendant · 5 generations on · 2 of its ownK090925 Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K031615Sled Curing Light SystemDentsply International · 2003 · cites it directly13descendants
- K041372Smartlite PS Pen-Style Led Curing LightDentsply International · 2004 · 2 generations on12descendants
- K063529Pencure, Model VL-7J. Morita USA, Inc. · 2007 · 3 generations on7descendants
- K071190Root ZX IIJ. Morita USA, Inc. · 2007 · 4 generations on6descendants
- K090925Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000393 | Nova Cordless Curing Light | Nova/Da Vinci Systems, Inc. | 2000 | — |
| +1 | K031615 | Sled Curing Light System | Dentsply International | 2003 | — |
| +2 | K041372 | Smartlite PS Pen-Style Led Curing Light | Dentsply International | 2004 | — |
| +3 | K063529 | Pencure, Model VL-7 | J. Morita USA, Inc. | 2007 | — |
| +4 | K071190 | Root ZX II | J. Morita USA, Inc. | 2007 | — |
| +5 | K090925 | Multiple (Apex Locator), Model RCM-7 | J. Morita USA, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 152 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?
- Of its descendants, K031615 (Dentsply International, 2003) has gone furthest, with 13 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.
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 | — |
https://510kreport.com/device/K000393 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000393: Nova Cordless Curing Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000393
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026