510(k) · Cleared
ClearedImplant Handpieces
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Sep 6, 2005 as substantially equivalent to K011061 (W&H Dentalwerk Buermoos GmbH, 2001) after a 76-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Sep 6, 2005
- Review
- 76 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011061 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK011061 Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92…W&H Dentalwerk Buermoos GmbH · 2001
- This deviceK051661 Implant HandpiecesSirona Dental Systems GmbH · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011061 | Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical… | W&H Dentalwerk Buermoos GmbH | 2001 | — |
| 0 (this device) | K051661 | Implant Handpieces | Sirona Dental Systems GmbH | 2005 | — |
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 EKX? 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 EKX device
- #1 K261987 Reusable SmartPegscore 13.2 · 5 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 |
|---|---|---|---|
| * | K011061 | Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight… | 2001 |
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?
- Its one ancestor has no recall.
- 9 other devices also cite its predicate K011061.
How does its category compare?
All EKX devicesEKX Handpiece, Direct Drive, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EKX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EKX
244in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EKX
No recall names EKX since 2007.
Adverse event reports per year · EKX
9in 2025
MAUDE reports naming product code EKX, 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 | 1 | — | 0 | 9 |
| 2008 | 3 | 101 | 0 | 10 |
| 2009 | 4 | 186 | 0 | 11 |
| 2010 | 3 | 114 | 0 | 20 |
| 2011 | 4 | 75 | 0 | 6 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 2 | — | 0 | 45 |
| 2014 | 3 | 251 | 0 | 102 |
| 2015 | 3 | 178 | 0 | 68 |
| 2016 | 3 | 274 | 0 | 66 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 3 | 293 | 0 | 49 |
| 2019 | 3 | 349 | 0 | 56 |
| 2020 | 1 | — | 0 | 67 |
| 2021 | 5 | 214 | 0 | 79 |
| 2022 | 3 | 359 | 0 | 37 |
| 2023 | 4 | 152 | 0 | 14 |
| 2024 | 4 | 276 | 0 | 19 |
| 2025 | 5 | 244 | 0 | 9 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Sirona Implant 20:1/80:1 Contra-angle handpieces are indicated for surgery,
implantology and general dental applications (drilling, grinding etc.).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051661: Implant Handpieces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051661
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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