510(k) · Cleared
ClearedRoot ZX II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Aug 17, 2007 as substantially equivalent to K031204 (J. Morita USA, Inc., 2003) and 1 other predicate after a 109-day review. Its family tree reaches back 5 generations to 1995. 6 later devices descend from it.
- Decided
- Aug 17, 2007
- Review
- 109 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K951425 (1995). 10 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK951425 Spectrum Curing Light Polymerization UnitDentsply Intl. · 1995
- 4 generations backK982318 Spectrum 800 Curing UnitDentsply Intl. · 1998
- 3 generations backK031615 Sled Curing Light SystemDentsply International · 2003
- 2 generations backK041372 Smartlite PS Pen-Style Led Curing LightDentsply International · 2004
- 1 generation backK063529 Pencure, Model VL-7J. Morita USA, Inc. · 2007
- This deviceK071190 Root ZX IIJ. Morita USA, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK090925 Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK151274 Dr's FinderGood Doctors Co., Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK112665 Tri Auto Mini - Endodeontic Treatment Motorized HandpieceJ. Morita USA, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK210475 EQ-MMeta Systems Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK213477 Root ZX3J. Morita USA, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K090925Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009 · cites it directly2descendants
- K151274Dr's FinderGood Doctors Co., Ltd. · 2016 · 2 generations on1descendant
- K112665Tri Auto Mini - Endodeontic Treatment Motorized HandpieceJ. Morita USA, Inc. · 2012 · cites it directly1descendant
- K210475EQ-MMeta Systems Co., Ltd. · 2022 · 2 generations on0descendants
- K213477Root ZX3J. Morita USA, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951425 | Spectrum Curing Light Polymerization Unit | Dentsply Intl. | 1995 | — |
| −4 | K982318 | Spectrum 800 Curing Unit | Dentsply Intl. | 1998 | — |
| −3 | K031615 | Sled Curing Light System | Dentsply International | 2003 | — |
| −2 | K041372 | Smartlite PS Pen-Style Led Curing Light | Dentsply International | 2004 | — |
| −1 | K063529 | Pencure, Model VL-7 | J. Morita USA, Inc. | 2007 | — |
| 0 (this device) | K071190 | Root ZX II | J. Morita USA, Inc. | 2007 | — |
| +1 | K090925 | Multiple (Apex Locator), Model RCM-7 | J. Morita USA, Inc. | 2009 | — |
| +2 | K151274 | Dr's Finder | Good Doctors Co., Ltd. | 2016 | — |
| +1 | K112665 | Tri Auto Mini - Endodeontic Treatment Motorized Handpiece | J. Morita USA, Inc. | 2012 | — |
| +2 | K210475 | EQ-M | Meta Systems Co., Ltd. | 2022 | — |
| +1 | K213477 | Root ZX3 | J. Morita USA, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 EKX? 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 EKX device
- #1 K261987 Reusable SmartPegscore 13.2 · 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 |
|---|---|---|---|
| * | K031204 | Dentaport ZXSummary page 2…E DESCRIPTION/SUBSTANTIAL EQUIVALENCE DEVICE DESCRIPTION The DP-ZX-VL is a dental device, built up simply by adding the same function as VL-7 (K063529) to the DP-ZX (K031204) . There are almost no new differences created in functions and structures. The DP-ZX-VL is composed of a Canal Measurement Modu… | 2003 |
| * | K063529 | Pencure, Model VL-7Summary page 2…6. DEVICE DESCRIPTION/SUBSTANTIAL EQUIVALENCE DEVICE DESCRIPTION The DP-ZX-VL is a dental device, built up simply by adding the same function as VL-7 (K063529) to the DP-ZX (K031204) . There are almost no new differences created in functions and structures. The DP-ZX-VL is composed of a… | 2007 |
What descends from it? (6)
3 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 12 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K090925 (J. Morita USA, Inc., 2009) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K031204.
How does its category compare?
All EKX devicesEKX Handpiece, Direct Drive, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · EKX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EKX
244in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EKX
No recall names EKX since 2007.
Adverse event reports per year · EKX
9in 2025
MAUDE reports naming product code EKX, 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 | 1 | — | 0 | 9 |
| 2008 | 3 | 101 | 0 | 10 |
| 2009 | 4 | 186 | 0 | 11 |
| 2010 | 3 | 114 | 0 | 20 |
| 2011 | 4 | 75 | 0 | 6 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 2 | — | 0 | 45 |
| 2014 | 3 | 251 | 0 | 102 |
| 2015 | 3 | 178 | 0 | 68 |
| 2016 | 3 | 274 | 0 | 66 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 3 | 293 | 0 | 49 |
| 2019 | 3 | 349 | 0 | 56 |
| 2020 | 1 | — | 0 | 67 |
| 2021 | 5 | 214 | 0 | 79 |
| 2022 | 3 | 359 | 0 | 37 |
| 2023 | 4 | 152 | 0 | 14 |
| 2024 | 4 | 276 | 0 | 19 |
| 2025 | 5 | 244 | 0 | 9 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
DP-ZX-VL is a dental device, composed of a "Canal Measurement Module" and "Handpiece / LED Module".
The former can measure the length of the root canal.
The latter can enlarge the root canal while monitoring the position of the file tip inside the canal, and can be used to polymerize (set) resinous and other materials by light from the Light Cure Handpiece head.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071190 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071190: Root ZX II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071190
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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