510(k) · Cleared
ClearedYoung INFINITY Cordless Handpiece System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Young Dental Manufacturing Co. 1, LLC · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Aug 20, 2018 as substantially equivalent to K110753 (Dentsply International, Inc., 2011) after a 467-day review. Its family tree reaches back 2 generations to 2010. 2 later devices descend from it.
- Decided
- Aug 20, 2018
- Review
- 467 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K101612 (2010). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK101612 Zen Cordless Prophy SystemDiscus Dental, LLC · 2010
- 1 generation backK110753 Midwest RDH Freedom Cordless Prophy SystemDentsply International, Inc. · 2011
- This deviceK171377 Young INFINITY Cordless Handpiece SystemYoung Dental Manufacturing Co. 1, LLC · 2018
- Descendant · cites it directly · 0 of its ownK211531 Cordless Prophy System, Model: i-PolishGuilin Woodpecker Medical Instrument Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK201703 PROXEO Twist Cordless Polishing System PL-40 HW&H Dentalwerk Buermoos GmbH · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K101612 | Zen Cordless Prophy System | Discus Dental, LLC | 2010 | — |
| −1 | K110753 | Midwest RDH Freedom Cordless Prophy System | Dentsply International, Inc. | 2011 | — |
| 0 (this device) | K171377 | Young INFINITY Cordless Handpiece System | Young Dental Manufacturing Co. 1, LLC | 2018 | — |
| +1 | K211531 | Cordless Prophy System, Model: i-Polish | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021 | — |
| +1 | K201703 | PROXEO Twist Cordless Polishing System PL-40 H | W&H Dentalwerk Buermoos GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K110753 | Midwest RDH Freedom Cordless Prophy SystemSummary page 5…ITY Cordless Handpiece System V. PREDICATE DEVICE Trade Name: Midwest RDH Freedom Cordless Prophy System Common Name: Prophy System 510(k) Number: K110753 (Decision Date: June 6, 2011) Manufacturer: Dentsply International Inc. VI. DEVICE DESCRIPTION The proposed dev… | 2011 |
What descends from it? (2)
2 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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K211531 (Guilin Woodpecker Medical Instrument Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K110753.
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. 2018, 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 for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing of tooth surfaces and fillings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171377: Young INFINITY Cordless Handpiece System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171377
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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