# K101612: Zen Cordless Prophy System

- Pathway: 510(k) (Traditional)
- Applicant: Discus Dental, LLC
- Decided: Jun 30, 2010 after 21 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K110753: Midwest RDH Freedom Cordless Prophy System (2011), 5 descendants of its own
- K171377: Young INFINITY Cordless Handpiece System (2018), 2 descendants of its own
- K211531: Cordless Prophy System, Model: i-Polish (2021), 0 descendants of its own
- K201703: PROXEO Twist Cordless Polishing System PL-40 H (2021), 0 descendants of its own
- K160825: MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology (2016), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K101612
Methodology: https://510kreport.com/methodology