# K171377: Young INFINITY Cordless Handpiece System

- Pathway: 510(k) (Traditional)
- Applicant: Young Dental Manufacturing Co. 1, LLC
- Decided: Aug 20, 2018 after 467 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.
2 later devices descend from it; 2 cite it directly.
0 of 5 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 5.

## Most influential descendants
- 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

## Indications for use
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.

Source page: https://510kreport.com/device/K171377
Methodology: https://510kreport.com/methodology