510(k) Report

510(k) · Cleared

Cleared

Zen Cordless Prophy System

K101612510(k) TraditionalCleared Jun 30, 201021-day reviewClass I21 CFR 872.4200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Discus Dental, LLC · EKX Handpiece, Direct Drive, Ac-Powered

Cleared on Jun 30, 2010 after a 21-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
Jun 30, 2010
Review
21 days
Class
Class I
Product code
EKX
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2018: 1 descendant cleared2016: 1 descendant cleared2013: 1 descendant cleared2021: 2 descendants cleared2010201520202025
  1. This deviceK101612 Zen Cordless Prophy SystemDiscus Dental, LLC · 2010
  2. Descendant · cites it directly · 5 of its ownK110753 Midwest RDH Freedom Cordless Prophy SystemDentsply International, Inc. · 2011
  3. Descendant · 2 generations on · 2 of its ownK171377 Young INFINITY Cordless Handpiece SystemYoung Dental Manufacturing Co. 1, LLC · 2018
  4. Descendant · 3 generations on · 0 of its ownK211531 Cordless Prophy System, Model: i-PolishGuilin Woodpecker Medical Instrument Co., Ltd. · 2021
  5. Descendant · 3 generations on · 0 of its ownK201703 PROXEO Twist Cordless Polishing System PL-40 HW&H Dentalwerk Buermoos GmbH · 2021
  6. Descendant · 2 generations on · 0 of its ownK160825 MIDWEST RDH Freedom Cordless Prophy System with SmartMode TechnologyDentsply Sirona · 2016

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2011: 12013: 12016: 12018: 12021: 2
2011high 2 (2021) · low 0 (2012)2026

Most influential descendants

Showing 5 of 6 · See all
  • K110753Midwest RDH Freedom Cordless Prophy SystemDentsply International, Inc. · 2011 · cites it directly5descendants
  • K171377Young INFINITY Cordless Handpiece SystemYoung Dental Manufacturing Co. 1, LLC · 2018 · 2 generations on2descendants
  • K211531Cordless Prophy System, Model: i-PolishGuilin Woodpecker Medical Instrument Co., Ltd. · 2021 · 3 generations on0descendants
  • K201703PROXEO Twist Cordless Polishing System PL-40 HW&H Dentalwerk Buermoos GmbH · 2021 · 3 generations on0descendants
  • K160825MIDWEST RDH Freedom Cordless Prophy System with SmartMode TechnologyDentsply Sirona · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K101612Zen Cordless Prophy SystemDiscus Dental, LLC2010—
+1K110753Midwest RDH Freedom Cordless Prophy SystemDentsply International, Inc.2011—
+2K171377Young INFINITY Cordless Handpiece SystemYoung Dental Manufacturing Co. 1, LLC2018—
+3K211531Cordless Prophy System, Model: i-PolishGuilin Woodpecker Medical Instrument Co., Ltd.2021—
+3K201703PROXEO Twist Cordless Polishing System PL-40 HW&H Dentalwerk Buermoos GmbH2021—
+2K160825MIDWEST RDH Freedom Cordless Prophy System with SmartMode TechnologyDentsply Sirona2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201310
201610
201810
202120
FIG. 1 — Lineage of K101612, 2010–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261987 Reusable SmartPegscore 13.2 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110753Midwest RDH Freedom Cordless Prophy SystemDentsply International, Inc.20115

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, K110753 (Dentsply International, Inc., 2011) has gone furthest, with 5 descendants of its own.

How does its category compare?

All EKX devices

EKX Handpiece, Direct Drive, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · EKX

5in 2025

2007: 12008: 32009: 42010: 32011: 42012: 22013: 22014: 32015: 32016: 32017: 22018: 32019: 32020: 12021: 52022: 32023: 42024: 42025: 52026 (partial year): 1
2007high 5 (2021) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EKX

244in 2025

2008: 101 days median2009: 186 days median2010: 114 days median2011: 75 days median2014: 251 days median2015: 178 days median2016: 274 days median2018: 293 days median2019: 349 days median2021: 214 days median2022: 359 days median2023: 152 days median2024: 276 days median2025: 244 days median
2007high 359 (2022) · low 75 (2011)2026

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

2007: 92008: 102009: 112010: 202011: 62012: 272013: 452014: 1022015: 682016: 662017: 102018: 492019: 562020: 672021: 792022: 372023: 142024: 192025: 9
2007high 102 (2014) · low 6 (2011)2025

MAUDE reports naming product code EKX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—09
20083101010
20094186011
20103114020
201147506
20122—027
20132—045
201432510102
20153178068
20163274066
20172—010
20183293049
20193349056
20201—067
20215214079
20223359037
20234152014
20244276019
2025524409
20261—0—

What is it indicated for?

The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiecee with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.

Indications for use as stated in the FDA 510(k) statement.

More from Discus Dental, LLC

5 FDA decisions under this applicant name. See the company

  • K102639SL3Discus Dental, LLC · 20101 recall
  • K101215NuanceDiscus Dental, LLC · 2010
  • K093208SimplisealDiscus Dental, LLC · 2010
  • K092417Insight Ultrasonic InsertsDiscus Dental, LLC · 2009

Recent decisions in EKX

The EKX category page

  • K261987Reusable SmartPegOsstell AB · 2026
  • K252223Alpha Endo Handpiece (Alpha Endo)Shenzhen Superline Technology CO., LTD. · 2025
  • K251597InnerView SystemPerimetrics, Inc. · 2025
  • K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L. · 2025
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https://510kreport.com/device/K101612 · printed Nov 4, 2026

Cite this page

510(k) Report. “K101612: Zen Cordless Prophy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101612

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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