# K143448: Sonendo GentleWave System

- Pathway: 510(k) (Traditional)
- Applicant: Sonendo, Inc.
- Decided: May 1, 2015 after 150 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: 3 generations back to K081268 (2009). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133752: Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure Kit, Sonendo, Inc. (2014) Summary page 4.

## Most influential descendants
- K233844: OdneClean (2024), 0 descendants of its own

## Indications for use
The Sonendo GentleWave System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave Molar Handpiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.

Source page: https://510kreport.com/device/K143448
Methodology: https://510kreport.com/methodology