510(k) · Cleared
ClearedSmartlite PS Pen-Style Led Curing Light
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 Jun 24, 2004 as substantially equivalent to K031615 (Dentsply International, 2003) and 1 other predicate after a 31-day review. Its family tree reaches back 3 generations to 1995. 12 later devices descend from it.
- Decided
- Jun 24, 2004
- Review
- 31 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K951425 (1995). 4 ancestors in all. 12 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK951425 Spectrum Curing Light Polymerization UnitDentsply Intl. · 1995
- 2 generations backK982318 Spectrum 800 Curing UnitDentsply Intl. · 1998
- 1 generation backK031615 Sled Curing Light SystemDentsply International · 2003
- This deviceK041372 Smartlite PS Pen-Style Led Curing LightDentsply International · 2004
- Descendant · cites it directly · 7 of its ownK063529 Pencure, Model VL-7J. Morita USA, Inc. · 2007
- Descendant · 2 generations on · 6 of its ownK071190 Root ZX IIJ. Morita USA, Inc. · 2007
- Descendant · 3 generations on · 2 of its ownK090925 Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009
- Descendant · 4 generations on · 1 of its ownK151274 Dr's FinderGood Doctors Co., Ltd. · 2016
- Descendant · 3 generations on · 1 of its ownK112665 Tri Auto Mini - Endodeontic Treatment Motorized HandpieceJ. Morita USA, Inc. · 2012
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K063529Pencure, Model VL-7J. Morita USA, Inc. · 2007 · cites it directly7descendants
- K071190Root ZX IIJ. Morita USA, Inc. · 2007 · 2 generations on6descendants
- K090925Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009 · 3 generations on2descendants
- K151274Dr's FinderGood Doctors Co., Ltd. · 2016 · 4 generations on1descendant
- K112665Tri Auto Mini - Endodeontic Treatment Motorized HandpieceJ. Morita USA, Inc. · 2012 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951425 | Spectrum Curing Light Polymerization Unit | Dentsply Intl. | 1995 | — |
| −2 | K982318 | Spectrum 800 Curing Unit | Dentsply Intl. | 1998 | — |
| −1 | K031615 | Sled Curing Light System | Dentsply International | 2003 | — |
| 0 (this device) | K041372 | Smartlite PS Pen-Style Led Curing Light | Dentsply International | 2004 | — |
| +1 | K063529 | Pencure, Model VL-7 | J. Morita USA, Inc. | 2007 | — |
| +2 | K071190 | Root ZX II | J. Morita USA, Inc. | 2007 | — |
| +3 | K090925 | Multiple (Apex Locator), Model RCM-7 | J. Morita USA, Inc. | 2009 | — |
| +4 | K151274 | Dr's Finder | Good Doctors Co., Ltd. | 2016 | — |
| +3 | K112665 | Tri Auto Mini - Endodeontic Treatment Motorized Handpiece | J. Morita USA, Inc. | 2012 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K031615 | Sled Curing Light SystemSummary page 1…LASSIFICATION NAME: Ultraviolet Activator for Polymerization (872.6070) PREDICATE DEVICES: SmartLiteTM iQ LED Curing Light K031615 SpectrumTM 800 Curing Unit K982318 DEVICE DESCRIPTION: The SmartLiteTM PS Pen… | 2003 |
| * | K982318 | Spectrum 800 Curing UnitSummary page 1….6070) PREDICATE DEVICES: SmartLiteTM iQ LED Curing Light K031615 SpectrumTM 800 Curing Unit K982318 DEVICE DESCRIPTION: The SmartLiteTM PS Pen-Style LED Curing Light is a cordless, battery-powered unit designed for curing VLC m… | 1998 |
What descends from it? (12)
See all 125 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 9 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K063529 (J. Morita USA, Inc., 2007) has gone furthest, with 7 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 | — |
What is it indicated for?
The SmartLiteTM PS Pen-Style LED Curing Light is indicated for curing campliorquinone-based visible light cured (VLC) dental materials
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041372 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041372: Smartlite PS Pen-Style Led 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/K041372
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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