510(k) · Cleared
Recalled · Class II · 2017Drilltech, Ism, Implantunit, Zimmer Surgical Motor System
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 May 3, 2006 as substantially equivalent to K002469 (W&H Dentalwerk Buermoos GmbH, 2001) and 1 other predicate after an 86-day review. Its family tree reaches back 2 generations to 2001. It has been recalled once.
- Decided
- May 3, 2006
- Review
- 86 days
- Class
- Class I
- Product code
- EBW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002469 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK002469 Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)W&H Dentalwerk Buermoos GmbH · 2001
- 1 generation backK052741 Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version)…W&H Dentalwerk Buermoos GmbH · 2006
- This deviceK060287 Drilltech, Ism, Implantunit, Zimmer Surgical Motor SystemW&H Dentalwerk Buermoos GmbH · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002469 | Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH | 2001 | — |
| −1 | K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl.… | W&H Dentalwerk Buermoos GmbH | 2006 | — |
| 0 (this device) | K060287 | Drilltech, Ism, Implantunit, Zimmer Surgical Motor System | W&H Dentalwerk Buermoos GmbH | 2006 | — |
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? (2)
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 |
|---|---|---|---|
| * | K002469 | Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)Summary page 1…implantology and maxillo surgery Classification Name: Controller, foot, handpiece and cord Predicate devices: implantMED SI-95 (K002469) implantmed SI 91 5/923 (K052741) Device Description: The device consists of a small hand held mot… | 2001 |
| * | K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. AccessoriesSummary page 1…lassification Name: Controller, foot, handpiece and cord Predicate devices: implantMED SI-95 (K002469) implantmed SI 91 5/923 (K052741) Device Description: The device consists of a small hand held motor, a foot control and a controller. Accessories complete t… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2017 | Class II | Z-1351-2018 | Process change control | During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot control might not switch back to zero position when the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 4.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K002469.
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?
Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964. The equipment is a drive unit for use in dental surgery, implantology and maxillo-facial surgery for treatment of dental hard tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060287 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060287: Drilltech, Ism, Implantunit, Zimmer Surgical Motor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060287
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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