510(k) · Cleared
ClearedProphy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate (600RPM Max.)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nsk Nakanishi, Inc. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Mar 24, 1999 after a 21-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 24 later devices descend from it.
- Decided
- Mar 24, 1999
- Review
- 21 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 2 citing it directly.
- This deviceK990682 Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max)…Nsk Nakanishi, Inc. · 1999
- Descendant · cites it directly · 20 of its ownK092614 X-Smart EasyDentsply Interntional · 2009
- Descendant · 2 generations on · 10 of its ownK111616 E-CUBESaeshin Precision Co., Ltd. · 2011
- Descendant · 2 generations on · 8 of its ownK103653 E3 Torque Control MotorDentsply International, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK133298 Endo SmartMeta Biomed, Inc. · 2014
- Descendant · 3 generations on · 5 of its ownK153285 EMS-200Meta Systems Co., Ltd. · 2016
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K092614X-Smart EasyDentsply Interntional · 2009 · cites it directly20descendants
- K111616E-CUBESaeshin Precision Co., Ltd. · 2011 · 2 generations on10descendants
- K103653E3 Torque Control MotorDentsply International, Inc. · 2011 · 2 generations on8descendants
- K133298Endo SmartMeta Biomed, Inc. · 2014 · 2 generations on6descendants
- K153285EMS-200Meta Systems Co., Ltd. · 2016 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990682 | Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate… | Nsk Nakanishi, Inc. | 1999 | — |
| +1 | K092614 | X-Smart Easy | Dentsply Interntional | 2009 | — |
| +2 | K111616 | E-CUBE | Saeshin Precision Co., Ltd. | 2011 | — |
| +2 | K103653 | E3 Torque Control Motor | Dentsply International, Inc. | 2011 | — |
| +2 | K133298 | Endo Smart | Meta Biomed, Inc. | 2014 | — |
| +3 | K153285 | EMS-200 | Meta Systems Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (24)
See all 242 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?
- Of its descendants, K092614 (Dentsply Interntional, 2009) has gone furthest, with 20 descendants of its own.
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?
This device, a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm, and is intended for use in light general dental, prophylaxis, or endodontic works, where low speed is required.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990682 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990682: Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate (600RPM Max.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990682
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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