510(k) · Cleared
ClearedA-dec NLZ Electric 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 May 11, 2017 as substantially equivalent to K133776 (A-Dec, Inc., 2014) after a 184-day review. Its family tree reaches back 2 generations to 2003. 4 later devices descend from it.
- Decided
- May 11, 2017
- Review
- 184 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032572 (2003). 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK032572 A-Dec/W&H Electric Motor, Model EA-50LTA-Dec, Inc. · 2003
- 1 generation backK133776 A-Dec/W&H Electric Handpiece MotorA-Dec, Inc. · 2014
- This deviceK163131 A-dec NLZ Electric Motor SystemNakanishi, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK251811 Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK202963 ELEC Master, ELEC Master DualMgnewton, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK202075 Dental Electric MotorFoshan Cicada Dental Instrument Co, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK203706 Dental Electric MotorGuilin Woodpecker Medical Instrument Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025 · cites it directly0descendants
- K202963ELEC Master, ELEC Master DualMgnewton, Ltd. · 2023 · cites it directly0descendants
- K202075Dental Electric MotorFoshan Cicada Dental Instrument Co, Ltd. · 2022 · cites it directly0descendants
- K203706Dental Electric MotorGuilin Woodpecker Medical Instrument Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032572 | A-Dec/W&H Electric Motor, Model EA-50LT | A-Dec, Inc. | 2003 | — |
| −1 | K133776 | A-Dec/W&H Electric Handpiece Motor | A-Dec, Inc. | 2014 | — |
| 0 (this device) | K163131 | A-dec NLZ Electric Motor System | Nakanishi, Inc. | 2017 | — |
| +1 | K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | 2025 | — |
| +1 | K202963 | ELEC Master, ELEC Master Dual | Mgnewton, Ltd. | 2023 | — |
| +1 | K202075 | Dental Electric Motor | Foshan Cicada Dental Instrument Co, Ltd. | 2022 | — |
| +1 | K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K133776 | A-Dec/W&H Electric Handpiece MotorSummary page 5…ge 5 === f. Predicate devices The A-dec NLZ electric motor system is substantially equivalent to the following legally marketed device: 510(k): K133776 Trade name: A-dec/W&H Electric Motor, Model EA-53 Product code: EBW g. Description of the device… | 2014 |
What descends from it? (4)
4 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 14 years and passes through 2 companies; a new generation was cleared every 10.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K251811 (Dentsply Sirona, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K133776.
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 A-dec NLZ electric motor system is comprised of a control unit that drives a direct current (DC) electric micromotor that is activated by means of a foot control. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163131 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163131: A-dec NLZ Electric Motor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163131
Report an extraction error
Are you the manufacturer?
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