510(k) · Cleared
ClearedCordless Prophy System, Model: i-Polish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guilin Woodpecker Medical Instrument Co., Ltd. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Dec 17, 2021 as substantially equivalent to K171377 (Young Dental Manufacturing Co. 1, LLC, 2018) after a 214-day review. Its family tree reaches back 3 generations to 2010.
- Decided
- Dec 17, 2021
- Review
- 214 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 deviceK211531 Cordless Prophy System, Model: i-PolishGuilin Woodpecker Medical Instrument Co., Ltd. · 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) | K211531 | Cordless Prophy System, Model: i-Polish | Guilin Woodpecker Medical Instrument Co., Ltd. | 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 5…cate Device Manufacturer Young Dental Manufacturing Co 1, LLC Device name Young INFINITY Cordless Handpiece System 510(K) Number: K171377 Regulation Description Dental handpiece and accessories Product Code EKX 4. Reference Device Manuf… | 2018 |
| † | K983413 | Model MS-1 Handpiece | 1998 |
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 3.3 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?
i-Polish is a cordless prophylaxis handpiece equipped with control buttons and wireless foot control for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211531: Cordless Prophy System, Model: i-Polish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211531
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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