510(k) · Cleared
ClearedA-Dec/W&H Electric Motor, Model EA-50LT
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 Dec 3, 2003 after a 105-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Dec 3, 2003
- Review
- 105 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK032572 A-Dec/W&H Electric Motor, Model EA-50LTA-Dec, Inc. · 2003
- Descendant · cites it directly · 10 of its ownK133776 A-Dec/W&H Electric Handpiece MotorA-Dec, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK181858 Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH · 2019
- Descendant · 2 generations on · 4 of its ownK163131 A-dec NLZ Electric Motor SystemNakanishi, Inc. · 2017
- Descendant · 3 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 · 3 generations on · 0 of its ownK251811 Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K133776A-Dec/W&H Electric Handpiece MotorA-Dec, Inc. · 2014 · cites it directly10descendants
- K181858Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH · 2019 · 2 generations on4descendants
- K163131A-dec NLZ Electric Motor SystemNakanishi, Inc. · 2017 · 2 generations on4descendants
- K213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER…Cefla S.C. · 2022 · 3 generations on1descendant
- K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K181858 | Electric Handpiece Motor | W&H Dentalwerk Buermoos GmbH | 2019 | — |
| +2 | K163131 | A-dec NLZ Electric Motor System | Nakanishi, Inc. | 2017 | — |
| +3 | K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy… | Cefla S.C. | 2022 | — |
| +3 | K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133776 | A-Dec/W&H Electric Handpiece Motor | 2014 | 10 |
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?
- Of its descendants, K133776 (A-Dec, Inc., 2014) has gone furthest, with 10 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.
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 510(k) statement.
https://510kreport.com/device/K032572 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032572: A-Dec/W&H Electric Motor, Model EA-50LT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032572
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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