# K160825: MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Sep 27, 2016 after 186 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
Longest line of descent: 2 generations back to K101612 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110753: Midwest RDH Freedom Cordless Prophy System, Dentsply International, Inc. (2011) Summary page 4.

## Indications for use
The MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology is a high-performance cordless prophylaxis handpiece with an optional wireless foot pedal for use with NUPRO Freedom® disposable prophy angles in a hygiene operatory to perform cleaning and polishing procedures on teeth.

Source page: https://510kreport.com/device/K160825
Methodology: https://510kreport.com/methodology