510(k) · Cleared
ClearedCEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cefla S.C. · EBW Controller, Foot, Handpiece And Cord
Cleared on Apr 1, 2024 as substantially equivalent to K213022 (Cefla S.C., 2022) after a 367-day review. Its family tree reaches back 7 generations to 1998.
- Decided
- Apr 1, 2024
- Review
- 367 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K983183 (1998). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK983183 Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora…Bien Air USA, Inc. · 1998
- 6 generations backK031145 Estylus Electric Motor SystemDentsply Intl. · 2003
- 5 generations backK072989 Axis SystemDentsply Intl., Inc. · 2008
- 4 generations backK143704 Advanced Air SystemW&H Dentalwerk Buermoos GmbH · 2015
- 3 generations backK162926 Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH · 2017
- 2 generations backK181858 Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH · 2019
- 1 generation backK213022 CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L…Cefla S.C. · 2022
- This deviceK230895 CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs…Cefla S.C. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K983183 | Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon… | Bien Air USA, Inc. | 1998 | — |
| −6 | K031145 | Estylus Electric Motor System | Dentsply Intl. | 2003 | — |
| −5 | K072989 | Axis System | Dentsply Intl., Inc. | 2008 | — |
| −4 | K143704 | Advanced Air System | W&H Dentalwerk Buermoos GmbH | 2015 | — |
| −3 | K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Burmoos GmbH | 2017 | — |
| −2 | 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 | — |
| 0 (this device) | K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO… | Cefla S.C. | 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 |
|---|---|---|---|
| * | K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER…Summary page 7…Imola, BO 40026 ITALY Owner/Operator: CEFLA Establishment Operations: Manufacturer 510 (k): K213022 Device Name: CEFLA Dental Micromotors i-MMr , i-MMr L , i-MMs ; i-XR3 , i-XR3 L , i-XS4 ; handy POWER , handy… | 2022 |
| † | K210550 | VALO Grand Corded and Accessory Lenses | 2021 |
| † | K220471 | VALO X, VALO X Accessory Lenses | 2022 |
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 3.1 years on median.
- None of the 12 ancestors has a recall.
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 CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed.
They are intended for professional use in dental surgery such as: preventive dentistry, restorative applications, endodontic treatment, prosthetic applications and implantology practices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230895: CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230895
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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