510(k) · Cleared
ClearedPencure, Model VL-7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Jan 5, 2007 as substantially equivalent to K051780 (J. Morita USA, Inc., 2005) and 1 other predicate after a 44-day review. Its family tree reaches back 4 generations to 1995. 7 later devices descend from it.
- Decided
- Jan 5, 2007
- Review
- 44 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K951425 (1995). 6 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK951425 Spectrum Curing Light Polymerization UnitDentsply Intl. · 1995
- 3 generations backK982318 Spectrum 800 Curing UnitDentsply Intl. · 1998
- 2 generations backK031615 Sled Curing Light SystemDentsply International · 2003
- 1 generation backK041372 Smartlite PS Pen-Style Led Curing LightDentsply International · 2004
- This deviceK063529 Pencure, Model VL-7J. Morita USA, Inc. · 2007
- Descendant · cites it directly · 6 of its ownK071190 Root ZX IIJ. Morita USA, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK090925 Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009
- Descendant · 3 generations on · 1 of its ownK151274 Dr's FinderGood Doctors Co., Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK112665 Tri Auto Mini - Endodeontic Treatment Motorized HandpieceJ. Morita USA, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK210475 EQ-MMeta Systems Co., Ltd. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K071190Root ZX IIJ. Morita USA, Inc. · 2007 · cites it directly6descendants
- K090925Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009 · 2 generations on2descendants
- K151274Dr's FinderGood Doctors Co., Ltd. · 2016 · 3 generations on1descendant
- K112665Tri Auto Mini - Endodeontic Treatment Motorized HandpieceJ. Morita USA, Inc. · 2012 · 2 generations on1descendant
- K210475EQ-MMeta Systems Co., Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951425 | Spectrum Curing Light Polymerization Unit | Dentsply Intl. | 1995 | — |
| −3 | K982318 | Spectrum 800 Curing Unit | Dentsply Intl. | 1998 | — |
| −2 | K031615 | Sled Curing Light System | Dentsply International | 2003 | — |
| −1 | K041372 | Smartlite PS Pen-Style Led Curing Light | Dentsply International | 2004 | — |
| 0 (this device) | K063529 | Pencure, Model VL-7 | J. Morita USA, Inc. | 2007 | — |
| +1 | K071190 | Root ZX II | J. Morita USA, Inc. | 2007 | — |
| +2 | K090925 | Multiple (Apex Locator), Model RCM-7 | J. Morita USA, Inc. | 2009 | — |
| +3 | K151274 | Dr's Finder | Good Doctors Co., Ltd. | 2016 | — |
| +2 | K112665 | Tri Auto Mini - Endodeontic Treatment Motorized Handpiece | J. Morita USA, Inc. | 2012 | — |
| +3 | K210475 | EQ-M | Meta Systems Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 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 |
|---|---|---|---|
| * | K051780 | Jetlite 5000Summary page 3…This is better expressed in the tabulated comparison ( Paragraph 9 below). 9. Substantial Equivalent comparison table FDA file reference number 51 0k number K051780 and K041372. Attachment inside notification submission file 51Ok FDA website print out Model name of Predicate Device JETL… | 2005 |
| * | K041372 | Smartlite PS Pen-Style Led Curing LightSummary page 3…er expressed in the tabulated comparison ( Paragraph 9 below). 9. Substantial Equivalent comparison table FDA file reference number 51 0k number K051780 and K041372. Attachment inside notification submission file 51Ok FDA website print out Model name of Predicate Device JETLITE 5000… | 2004 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071190 | Root ZX II | 2007 | 6 |
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 12 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K071190 (J. Morita USA, Inc., 2007) has gone furthest, with 6 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. 2007, 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?
The Pencure is intended to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by light from head.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063529 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063529: Pencure, Model VL-7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063529
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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