510(k) · Cleared
ClearedSpectrum Curing Light Polymerization Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on May 5, 1995 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.
- Decided
- May 5, 1995
- Review
- 39 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 1 citing it directly.
- This deviceK951425 Spectrum Curing Light Polymerization UnitDentsply Intl. · 1995
- Descendant · cites it directly · 16 of its ownK982318 Spectrum 800 Curing UnitDentsply Intl. · 1998
- Descendant · 2 generations on · 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
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K982318Spectrum 800 Curing UnitDentsply Intl. · 1998 · cites it directly16descendants
- K031615Sled Curing Light SystemDentsply International · 2003 · 2 generations on13descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951425 | Spectrum Curing Light Polymerization Unit | Dentsply Intl. | 1995 | — |
| +1 | K982318 | Spectrum 800 Curing Unit | Dentsply Intl. | 1998 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 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? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982318 | Spectrum 800 Curing Unit | 1998 | 16 |
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, K982318 (Dentsply Intl., 1998) has gone furthest, with 16 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/K951425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951425: Spectrum Curing Light Polymerization Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951425
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026