510(k) · Cleared
ClearedDental Electric Motor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guilin Woodpecker Medical Instrument Co., Ltd. · EBW Controller, Foot, Handpiece And Cord
Cleared on Jan 13, 2022 as substantially equivalent to K163131 (Nakanishi, Inc., 2017) after a 391-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Jan 13, 2022
- Review
- 391 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K032572 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK032572 A-Dec/W&H Electric Motor, Model EA-50LTA-Dec, Inc. · 2003
- 2 generations backK133776 A-Dec/W&H Electric Handpiece MotorA-Dec, Inc. · 2014
- 1 generation backK163131 A-dec NLZ Electric Motor SystemNakanishi, Inc. · 2017
- This deviceK203706 Dental Electric MotorGuilin Woodpecker Medical Instrument Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032572 | A-Dec/W&H Electric Motor, Model EA-50LT | A-Dec, Inc. | 2003 | — |
| −2 | K133776 | A-Dec/W&H Electric Handpiece Motor | A-Dec, Inc. | 2014 | — |
| −1 | K163131 | A-dec NLZ Electric Motor System | Nakanishi, Inc. | 2017 | — |
| 0 (this device) | K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K163131 | A-dec NLZ Electric Motor SystemSummary page 5…Primary predicate device Sponsor: Nakanishi, Inc. Device: A-dec NLZ electric motor system 510(K)Number: K163131 Reference device Sponsor: Nakanishi, Inc. Device: General Cutting Contr… | 2017 |
| † | K182999 | General Cutting Contra Handpiece | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K163131.
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. 2022, 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 MT2 dental electric motor consists of main unit, motor, motor tail, power adapter and power cord. 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. The Dental Electric Motor can be used with ISO E-type a straight, right-angle or contra-angle handpiece attachment of equal, gear-reducing, or gear increasing speed.
The contra-angle handpieces (model:WJ-15, WJ-15L) are driven by a micro-motor to rotate at a specified speed, so as to drive the dental bur. It is applicable to drilling and grinding in dental surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203706: Dental Electric Motor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203706
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