510(k) · Cleared
ClearedNLZ Motor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nakanishi, Inc. · EBW Controller, Foot, Handpiece And Cord
Cleared on Aug 31, 2017 as substantially equivalent to K090937 (Scican, Ltd., 2009) and 1 other predicate after a 269-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Aug 31, 2017
- Review
- 269 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K970339 (1997). 17 ancestors in all, the oldest K964860 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK970339 Tri Auto ZXJ. Morita USA, Inc. · 1997
- 4 generations backK022147 Denta PortJ. Morita USA, Inc. · 2002
- 3 generations backK031204 Dentaport ZXJ. Morita USA, Inc. · 2003
- 2 generations backK042822 TCM Endo V, Model 1534Nouvag AG · 2004
- 1 generation backK150750 Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH · 2015
- This deviceK163402 NLZ Motor SystemNakanishi, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK251701 Star E900 Electric SystemDentalez, Inc., Stardental Division · 2026
Most influential descendants
Showing 1 of 1 · See all- K251701Star E900 Electric SystemDentalez, Inc., Stardental Division · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970339 | Tri Auto ZX | J. Morita USA, Inc. | 1997 | — |
| −4 | K022147 | Denta Port | J. Morita USA, Inc. | 2002 | — |
| −3 | K031204 | Dentaport ZX | J. Morita USA, Inc. | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | K163402 | NLZ Motor System | Nakanishi, Inc. | 2017 | — |
| +1 | K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 EBW? 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 EBW device
- #1 K251701 Star E900 Electric Systemscore 12.2 · 6 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 |
|---|---|---|---|
| * | K090937 | E-Statis 40 SystemSummary page 5…1 NLZ Motor System Premarket Notification Traditional 510(k) f. Predicate devices and reference device Predicate device 510(k): K090937 Trade name: E-STATIS 40 Electric Motor System Company name: SciCAN Product code: EBW Th… | 2009 |
| * | K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySummary page 5…ce. Therefore, the predicate device for the contra-angle handpiece, NLZ Endo is shown below. Predicate device for the NLZ Endo 510(k): K150750 Trade name: Contra-Angle Handpiece :Endo 6:1 Company name: Sirona Dental Systems GmbH Pro… | 2015 |
| † | K103653 | E3 Torque Control Motor | 2011 |
| † | K103027 | Electrotorque TLC | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251701 | Star E900 Electric System | 2026 | 0 |
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 20 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K251701 (Dentalez, Inc., Stardental Division, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EBW devicesEBW Controller, Foot, Handpiece And Cord: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · EBW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBW
220in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBW
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBW
13in 2025
MAUDE reports naming product code EBW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 5 | 112 | 0 | 16 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 3 | 226 | 0 | 1 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 3 | 189 | 0 | 4 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 4 | 227 | 0 | 13 |
| 2018 | 1 | — | 0 | 46 |
| 2019 | 2 | — | 0 | 55 |
| 2020 | 1 | — | 0 | 71 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 6 | 479 | 0 | 31 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 4 | 268 | 0 | 14 |
| 2025 | 3 | 220 | 0 | 13 |
| 2026 | 3 | 269 | 0 | — |
What is it indicated for?
The NLZ Motor System is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.
The NLZ Endo is intended for use by dental professionals in the performance of dental endodontic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163402: NLZ Motor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163402
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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