510(k) · Cleared
ClearedTCM Endo V, Model 1534
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nouvag AG · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Dec 22, 2004 as substantially equivalent to K031204 (J. Morita USA, Inc., 2003) and 1 other predicate after a 71-day review. Its family tree reaches back 3 generations to 1997. 6 later devices descend from it.
- Decided
- Dec 22, 2004
- Review
- 71 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K970339 (1997). 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK970339 Tri Auto ZXJ. Morita USA, Inc. · 1997
- 2 generations backK022147 Denta PortJ. Morita USA, Inc. · 2002
- 1 generation backK031204 Dentaport ZXJ. Morita USA, Inc. · 2003
- This deviceK042822 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 · 1 of its ownK163402 NLZ Motor SystemNakanishi, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK123608 Endo E ClassSaeyang Microtech Co., Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK251701 Star E900 Electric SystemDentalez, Inc., Stardental Division · 2026
- Descendant · 2 generations on · 0 of its ownK141482 KI-20Saeyang Microtech Co., Ltd. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH · 2015 · cites it directly2descendants
- K163402NLZ Motor SystemNakanishi, Inc. · 2017 · 2 generations on1descendant
- K123608Endo E ClassSaeyang Microtech Co., Ltd. · 2013 · cites it directly1descendant
- K251701Star E900 Electric SystemDentalez, Inc., Stardental Division · 2026 · 3 generations on0descendants
- K141482KI-20Saeyang Microtech Co., Ltd. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970339 | Tri Auto ZX | J. Morita USA, Inc. | 1997 | — |
| −2 | K022147 | Denta Port | J. Morita USA, Inc. | 2002 | — |
| −1 | K031204 | Dentaport ZX | J. Morita USA, Inc. | 2003 | — |
| 0 (this device) | 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 | K163402 | NLZ Motor System | Nakanishi, Inc. | 2017 | — |
| +1 | K123608 | Endo E Class | Saeyang Microtech Co., Ltd. | 2013 | — |
| +3 | K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | 2026 | — |
| +2 | K141482 | KI-20 | Saeyang Microtech Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 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? (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 1…872.4200) Identification of thepredicate device orlegally marketed deviceordevices towhich substantial equivalence is being claimed: J. Morita USA, Inc. DENTAPORT ZX K031204, Cleared on 08/21/2003 J. Morita USA, Inc. DENTA PORT K022147, Cleared on 12/20/2002… | 2003 |
| * | K022147 | Denta PortSummary page 1…rketed deviceordevices towhich substantial equivalence is being claimed: J. Morita USA, Inc. DENTAPORT ZX K031204, Cleared on 08/21/2003 J. Morita USA, Inc. DENTA PORT K022147, Cleared on 12/20/2002 10-1 NOUVAG AG… | 2002 |
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 7 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K150750 (Sirona Dental Systems GmbH, 2015) 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.
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 TCM Endo V 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/K042822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042822: TCM Endo V, Model 1534.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042822
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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