# K233844: OdneClean

- Pathway: 510(k) (Traditional)
- Applicant: Odne AG
- Decided: Aug 8, 2024 after 248 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K081268 (2009). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143448: Sonendo GentleWave System, Sonendo, Inc. (2015) Summary page 5.
- K093000: Ems Piezon Master 700, E.M.S Electro Medical Systems S.A (2010) Summary page 5.
- K211721: PS System, Inter-Med, Inc. (2021) Summary page 5.

## Indications for use
OdneClean is intended to prepare, clean, and irrigate teeth indicated for root canal therapy.

Source page: https://510kreport.com/device/K233844
Methodology: https://510kreport.com/methodology