510(k) · Cleared
ClearedMidwest RDH Freedom Cordless Prophy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International, Inc. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Jun 6, 2011 as substantially equivalent to K101612 (Discus Dental, LLC, 2010) after an 80-day review. Its family tree reaches back 1 generation to 2010. 5 later devices descend from it.
- Decided
- Jun 6, 2011
- Review
- 80 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101612 (2010). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK101612 Zen Cordless Prophy SystemDiscus Dental, LLC · 2010
- This deviceK110753 Midwest RDH Freedom Cordless Prophy SystemDentsply International, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK171377 Young INFINITY Cordless Handpiece SystemYoung Dental Manufacturing Co. 1, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK211531 Cordless Prophy System, Model: i-PolishGuilin Woodpecker Medical Instrument Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK201703 PROXEO Twist Cordless Polishing System PL-40 HW&H Dentalwerk Buermoos GmbH · 2021
- Descendant · cites it directly · 0 of its ownK160825 MIDWEST RDH Freedom Cordless Prophy System with SmartMode TechnologyDentsply Sirona · 2016
- Descendant · cites it directly · 0 of its ownK131578 Iprophy MobileNakanishi, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K171377Young INFINITY Cordless Handpiece SystemYoung Dental Manufacturing Co. 1, LLC · 2018 · cites it directly2descendants
- K211531Cordless Prophy System, Model: i-PolishGuilin Woodpecker Medical Instrument Co., Ltd. · 2021 · 2 generations on0descendants
- K201703PROXEO Twist Cordless Polishing System PL-40 HW&H Dentalwerk Buermoos GmbH · 2021 · 2 generations on0descendants
- K160825MIDWEST RDH Freedom Cordless Prophy System with SmartMode TechnologyDentsply Sirona · 2016 · cites it directly0descendants
- K131578Iprophy MobileNakanishi, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101612 | Zen Cordless Prophy System | Discus Dental, LLC | 2010 | — |
| 0 (this device) | 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 | — |
| +2 | K211531 | Cordless Prophy System, Model: i-Polish | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021 | — |
| +2 | K201703 | PROXEO Twist Cordless Polishing System PL-40 H | W&H Dentalwerk Buermoos GmbH | 2021 | — |
| +1 | K160825 | MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology | Dentsply Sirona | 2016 | — |
| +1 | K131578 | Iprophy Mobile | Nakanishi, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
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 |
|---|---|---|---|
| * | K101612 | Zen Cordless Prophy System | 2010 |
What descends from it? (5)
3 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?
- Its one ancestor has no recall.
- Of its descendants, K171377 (Young Dental Manufacturing Co. 1, LLC, 2018) has gone furthest, with 2 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. 2011, 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?
The MIDWEST® RDH Freedom™ Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Freedom disposable prophylaxis angles in a hygiene operatory to perform cleaning and polishing procedures on teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110753 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110753: Midwest RDH Freedom Cordless Prophy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110753
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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