510(k) · Cleared
ClearedPROXEO Twist Cordless Polishing System PL-40 H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W&H Dentalwerk Buermoos GmbH · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Feb 24, 2021 as substantially equivalent to K171377 (Young Dental Manufacturing Co. 1, LLC, 2018) after a 247-day review. Its family tree reaches back 3 generations to 2010.
- Decided
- Feb 24, 2021
- Review
- 247 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K101612 (2010). No later device cites it as a predicate yet.
- Root · 3 generations backK101612 Zen Cordless Prophy SystemDiscus Dental, LLC · 2010
- 2 generations backK110753 Midwest RDH Freedom Cordless Prophy SystemDentsply International, Inc. · 2011
- 1 generation backK171377 Young INFINITY Cordless Handpiece SystemYoung Dental Manufacturing Co. 1, LLC · 2018
- This deviceK201703 PROXEO Twist Cordless Polishing System PL-40 HW&H Dentalwerk Buermoos GmbH · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K101612 | Zen Cordless Prophy System | Discus Dental, LLC | 2010 | — |
| −2 | K110753 | Midwest RDH Freedom Cordless Prophy System | Dentsply International, Inc. | 2011 | — |
| −1 | K171377 | Young INFINITY Cordless Handpiece System | Young Dental Manufacturing Co. 1, LLC | 2018 | — |
| 0 (this device) | K201703 | PROXEO Twist Cordless Polishing System PL-40 H | W&H Dentalwerk Buermoos GmbH | 2021 | — |
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 |
|---|---|---|---|
| * | K171377 | Young INFINITY Cordless Handpiece SystemSummary page 4…00 Regulatory class I Product Code EKX Device Name: Young INFINITY Cordless Handpiece System Predicate Devices 510(k) Number: K171377 (Decision Date: August 20th, 2018) Manufacturer: Young Dental Manufacturing Co. Th… | 2018 |
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 11 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K171377.
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. 2021, this device’s year, is highlighted.
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?
Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth surfaces and fillings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201703: PROXEO Twist Cordless Polishing System PL-40 H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201703
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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