510(k) · Cleared
ClearedDentaport ZX
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 21, 2003 as substantially equivalent to K022147 (J. Morita USA, Inc., 2002) after a 127-day review. Its family tree reaches back 2 generations to 1997. 15 later devices descend from it.
- Decided
- Aug 21, 2003
- Review
- 127 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970339 (1997). 15 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK970339 Tri Auto ZXJ. Morita USA, Inc. · 1997
- 1 generation backK022147 Denta PortJ. Morita USA, Inc. · 2002
- This deviceK031204 Dentaport ZXJ. Morita USA, Inc. · 2003
- Descendant · cites it directly · 6 of its ownK071190 Root ZX IIJ. Morita USA, Inc. · 2007
- Descendant · cites it directly · 6 of its ownK042822 TCM Endo V, Model 1534Nouvag AG · 2004
- Descendant · cites it directly · 2 of its ownK150750 Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH · 2015
- Descendant · 2 generations on · 2 of its ownK090925 Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK163402 NLZ Motor SystemNakanishi, Inc. · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K071190Root ZX IIJ. Morita USA, Inc. · 2007 · cites it directly6descendants
- K042822TCM Endo V, Model 1534Nouvag AG · 2004 · cites it directly6descendants
- K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH · 2015 · cites it directly2descendants
- K090925Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009 · 2 generations on2descendants
- K163402NLZ Motor SystemNakanishi, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970339 | Tri Auto ZX | J. Morita USA, Inc. | 1997 | — |
| −1 | K022147 | Denta Port | J. Morita USA, Inc. | 2002 | — |
| 0 (this device) | K031204 | Dentaport ZX | J. Morita USA, Inc. | 2003 | — |
| +1 | K071190 | Root ZX II | J. Morita USA, Inc. | 2007 | — |
| +1 | K042822 | TCM Endo V, Model 1534 | Nouvag AG | 2004 | — |
| +1 | K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | 2015 | — |
| +2 | K090925 | Multiple (Apex Locator), Model RCM-7 | J. Morita USA, Inc. | 2009 | — |
| +2 | K163402 | NLZ Motor System | Nakanishi, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K022147 | Denta PortSummary page 1…t canal length measuring device. The DENTAPORT ZX covered by this submission is identical in every respect to the DENTA PORT device already authorized by the FDA under K#022147. The only difference is a change in the instructions for use regarding the sterilization of the device. The new sterilization pa… | 2002 |
What descends from it? (15)
See all 154 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 6 years and passes through 1 company; a new generation was cleared every 5.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K071190 (J. Morita USA, Inc., 2007) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K022147.
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.
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?
The DENTAPORT ZX is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the canal while monitoring the position of the file tip inside the canal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031204: Dentaport ZX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031204
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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