# K201703: PROXEO Twist Cordless Polishing System PL-40 H

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: Feb 24, 2021 after 247 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: 3 generations back to K101612 (2010). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171377: Young INFINITY Cordless Handpiece System, Young Dental Manufacturing Co. 1, LLC (2018) Summary page 4.

## Indications for use
Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth surfaces and fillings.

Source page: https://510kreport.com/device/K201703
Methodology: https://510kreport.com/methodology