510(k) · Cleared
ClearedSled Curing Light System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Jul 21, 2003 as substantially equivalent to K982318 (Dentsply Intl., 1998) and 1 other predicate after a 59-day review. Its family tree reaches back 2 generations to 1995. 13 later devices descend from it.
- Decided
- Jul 21, 2003
- Review
- 59 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951425 (1995). 3 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK951425 Spectrum Curing Light Polymerization UnitDentsply Intl. · 1995
- 1 generation backK982318 Spectrum 800 Curing UnitDentsply Intl. · 1998
- This deviceK031615 Sled Curing Light SystemDentsply International · 2003
- Descendant · cites it directly · 12 of its ownK041372 Smartlite PS Pen-Style Led Curing LightDentsply International · 2004
- Descendant · 2 generations on · 7 of its ownK063529 Pencure, Model VL-7J. Morita USA, Inc. · 2007
- Descendant · 3 generations on · 6 of its ownK071190 Root ZX IIJ. Morita USA, Inc. · 2007
- Descendant · 4 generations on · 2 of its ownK090925 Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009
- Descendant · 5 generations on · 1 of its ownK151274 Dr's FinderGood Doctors Co., Ltd. · 2016
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K041372Smartlite PS Pen-Style Led Curing LightDentsply International · 2004 · cites it directly12descendants
- K063529Pencure, Model VL-7J. Morita USA, Inc. · 2007 · 2 generations on7descendants
- K071190Root ZX IIJ. Morita USA, Inc. · 2007 · 3 generations on6descendants
- K090925Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009 · 4 generations on2descendants
- K151274Dr's FinderGood Doctors Co., Ltd. · 2016 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951425 | Spectrum Curing Light Polymerization Unit | Dentsply Intl. | 1995 | — |
| −1 | K982318 | Spectrum 800 Curing Unit | Dentsply Intl. | 1998 | — |
| 0 (this device) | K031615 | Sled Curing Light System | Dentsply International | 2003 | — |
| +1 | K041372 | Smartlite PS Pen-Style Led Curing Light | Dentsply International | 2004 | — |
| +2 | K063529 | Pencure, Model VL-7 | J. Morita USA, Inc. | 2007 | — |
| +3 | K071190 | Root ZX II | J. Morita USA, Inc. | 2007 | — |
| +4 | K090925 | Multiple (Apex Locator), Model RCM-7 | J. Morita USA, Inc. | 2009 | — |
| +5 | K151274 | Dr's Finder | Good Doctors Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (2)
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 |
|---|---|---|---|
| * | K982318 | Spectrum 800 Curing UnitSummary page 2…NDED USE: Curing camphorquinone-based visible light cured (VLC) materials TECHNOLOGICAL CHARACTERISTICS: The SLED CURING LIGHT SYSTEM is substantially equivalent to K9823 18 in intended use, appearance and design, including source placement, probe style, on-board radiometer, control circuit, handpiece… | 1998 |
| * | K000393 | Nova Cordless Curing LightSummary page 1…ATE DEVICES: SpectrumTM800 Curing Unit 9823 I8 Nova Cordless Light 000393 DEVICE DESCRIPTION: The SLED CURING LIGHT is a cordless battery-powered unit designed for curing VLC materials whose initiat… | 2000 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041372 | Smartlite PS Pen-Style Led Curing Light | 2004 | 12 |
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 8 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K041372 (Dentsply International, 2004) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K982318.
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 | — |
What is it indicated for?
Curing camphorquinone-based visible light cured (VLC) materials
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031615: Sled Curing Light System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031615
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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