510(k) · Cleared
ClearedA-Dec/W&H Electric Handpiece Motor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A-Dec, Inc. · EBW Controller, Foot, Handpiece And Cord
Cleared on May 28, 2014 as substantially equivalent to K032572 (A-Dec, Inc., 2003) after a 167-day review. Its family tree reaches back 1 generation to 2003. 10 later devices descend from it.
- Decided
- May 28, 2014
- Review
- 167 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032572 (2003). 10 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK032572 A-Dec/W&H Electric Motor, Model EA-50LTA-Dec, Inc. · 2003
- This deviceK133776 A-Dec/W&H Electric Handpiece MotorA-Dec, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK181858 Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH · 2019
- Descendant · cites it directly · 4 of its ownK163131 A-dec NLZ Electric Motor SystemNakanishi, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK213022 CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L…Cefla S.C. · 2022
- Descendant · 2 generations on · 0 of its ownK251811 Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK233288 NLZ Built-In Motor SystemNakanishi, Inc. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K181858Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH · 2019 · cites it directly4descendants
- K163131A-dec NLZ Electric Motor SystemNakanishi, Inc. · 2017 · cites it directly4descendants
- K213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER…Cefla S.C. · 2022 · 2 generations on1descendant
- K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025 · 2 generations on0descendants
- K233288NLZ Built-In Motor SystemNakanishi, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032572 | A-Dec/W&H Electric Motor, Model EA-50LT | A-Dec, Inc. | 2003 | — |
| 0 (this device) | K133776 | A-Dec/W&H Electric Handpiece Motor | A-Dec, Inc. | 2014 | — |
| +1 | K181858 | Electric Handpiece Motor | W&H Dentalwerk Buermoos GmbH | 2019 | — |
| +1 | K163131 | A-dec NLZ Electric Motor System | Nakanishi, Inc. | 2017 | — |
| +2 | K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy… | Cefla S.C. | 2022 | — |
| +2 | K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | 2025 | — |
| +2 | K233288 | NLZ Built-In Motor System | Nakanishi, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K032572 | A-Dec/W&H Electric Motor, Model EA-50LTSummary page 1…r: 872.4200 Device Class:I Product Code: EBW Predicate Device A-decNV&H Electric Motor, Model EA-50LT (K032572) Device Description The A-dec/W&H Electric Motor, Model EA-53 is designed to accommodate existing and… | 2003 |
What descends from it? (10)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K181858 (W&H Dentalwerk Buermoos GmbH, 2019) has gone furthest, with 4 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. 2014, 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/W&H Electric Motor kit is a device system comprised of a control unit that drives a DC electric micromotor that is activated by means of a footswitch. 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 speed, gear-reduction speed, or gear-increasing speed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133776 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133776: A-Dec/W&H Electric Handpiece Motor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133776
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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