510(k) · Cleared
ClearedFiber Optic Brushless Electronic Micromotor, model: iM100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codent Technical Industry Co., Ltd. · EBW Controller, Foot, Handpiece And Cord
Cleared on Mar 11, 2024 as substantially equivalent to K181858 (W&H Dentalwerk Buermoos GmbH, 2019) after a 259-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Mar 11, 2024
- Review
- 259 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K983183 (1998). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK983183 Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora…Bien Air USA, Inc. · 1998
- 5 generations backK031145 Estylus Electric Motor SystemDentsply Intl. · 2003
- 4 generations backK072989 Axis SystemDentsply Intl., Inc. · 2008
- 3 generations backK143704 Advanced Air SystemW&H Dentalwerk Buermoos GmbH · 2015
- 2 generations backK162926 Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH · 2017
- 1 generation backK181858 Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH · 2019
- This deviceK231864 Fiber Optic Brushless Electronic Micromotor, model: iM100Codent Technical Industry Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983183 | Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon… | Bien Air USA, Inc. | 1998 | — |
| −5 | K031145 | Estylus Electric Motor System | Dentsply Intl. | 2003 | — |
| −4 | K072989 | Axis System | Dentsply Intl., Inc. | 2008 | — |
| −3 | K143704 | Advanced Air System | W&H Dentalwerk Buermoos GmbH | 2015 | — |
| −2 | K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Burmoos GmbH | 2017 | — |
| −1 | K181858 | Electric Handpiece Motor | W&H Dentalwerk Buermoos GmbH | 2019 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K181858 | Electric Handpiece MotorSummary page 5…lassification Product Code: EBW Regulation number: 872.4200 Device Class: I 510(k) Number: K181858 5.6 Indications for Use of the Device The Fiber Optic Brushless Electric Micromotor Set (iM100) is a brushless DC electric mic… | 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 26 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
- None of the 11 ancestors has a recall.
- 2 other devices also cite its predicate K181858.
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. 2024, 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 Fiber Optic Brushless Electric Micromotor Set (iM100) is a brushless DC electric micromotor controlled by a control unit. It is intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed. It 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231864 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231864: Fiber Optic Brushless Electronic Micromotor, model: iM100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231864
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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