510(k) · Cleared
ClearedElectric Handpiece Motor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W&H Dentalwerk Buermoos GmbH · EBW Controller, Foot, Handpiece And Cord
Cleared on Mar 26, 2019 as substantially equivalent to K133776 (A-Dec, Inc., 2014) and 2 other predicates after a 257-day review. Its family tree reaches back 5 generations to 1998. 4 later devices descend from it.
- Decided
- Mar 26, 2019
- Review
- 257 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K983183 (1998). 10 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK983183 Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora…Bien Air USA, Inc. · 1998
- 4 generations backK031145 Estylus Electric Motor SystemDentsply Intl. · 2003
- 3 generations backK072989 Axis SystemDentsply Intl., Inc. · 2008
- 2 generations backK143704 Advanced Air SystemW&H Dentalwerk Buermoos GmbH · 2015
- 1 generation backK162926 Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH · 2017
- This deviceK181858 Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH · 2019
- Descendant · cites it directly · 1 of its ownK213022 CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L…Cefla S.C. · 2022
- Descendant · cites it directly · 0 of its ownK233288 NLZ Built-In Motor SystemNakanishi, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK230895 CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs…Cefla S.C. · 2024
- Descendant · cites it directly · 0 of its ownK231864 Fiber Optic Brushless Electronic Micromotor, model: iM100Codent Technical Industry Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER…Cefla S.C. · 2022 · cites it directly1descendant
- K233288NLZ Built-In Motor SystemNakanishi, Inc. · 2024 · cites it directly0descendants
- K230895CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3…Cefla S.C. · 2024 · 2 generations on0descendants
- K231864Fiber Optic Brushless Electronic Micromotor, model: iM100Codent Technical Industry Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983183 | Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon… | Bien Air USA, Inc. | 1998 | — |
| −4 | K031145 | Estylus Electric Motor System | Dentsply Intl. | 2003 | — |
| −3 | K072989 | Axis System | Dentsply Intl., Inc. | 2008 | — |
| −2 | K143704 | Advanced Air System | W&H Dentalwerk Buermoos GmbH | 2015 | — |
| −1 | K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Burmoos GmbH | 2017 | — |
| 0 (this device) | K181858 | Electric Handpiece Motor | W&H Dentalwerk Buermoos GmbH | 2019 | — |
| +1 | K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy… | Cefla S.C. | 2022 | — |
| +1 | K233288 | NLZ Built-In Motor System | Nakanishi, Inc. | 2024 | — |
| +2 | K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO… | Cefla S.C. | 2024 | — |
| +1 | K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 3 | 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? (3)
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 4…the electric motor EM-12 L: “Electric Handpiece Motor”, A-dec/W&H cleared under Predicate Devices K133776 The W&H electric motor EM-12 L is designed to accommodate existing… | 2014 |
| * | K070663 | A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, a-Dec/W&H Synea…Summary page 4…EM-12 L is designed to accommodate existing and new handpiece attachments (already cleared for market under K070663 and K162926) for the purpose of performing dental procedures as des… | 2007 |
| * | K162926 | Air-Powered Handpieces and Handpiece AttachmentsSummary page 4…esigned to accommodate existing and new handpiece attachments (already cleared for market under K070663 and K162926) for the purpose of performing dental procedures as described above… | 2017 |
What descends from it? (4)
3 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 21 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K213022 (Cefla S.C., 2022) has gone furthest, with 1 descendant 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. 2019, 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?
Electric Handpiece Motor EM-12 L is a brushless DC electric micromotor controlled by a control unit.
The electrical drive, EM-12 L is indicated for use in the field of preventive dentistry, restorative applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181858: Electric Handpiece Motor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181858
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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