# K203302: GentleWave X

- Pathway: 510(k) (Traditional)
- Applicant: Sonendo, Inc.
- Decided: Feb 5, 2021 after 88 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: 2 generations back to K153157 (2016). 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)
- K160905: Sonendo GentleWave System, Sonendo, Inc. (2016) Summary page 4.

## Indications for use
The Sonendo Gentle Wave X System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo Gentle Wave Molar Procedure Instrument or Molar Crossfire™ Procedure Instrument, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave Anterior/Premolar Procedure Instrument, the System is indicated for anterior and premolar teeth. When used with the Sonendo Gentle Wave Premolar Crossfire™ Procedure Instrument, the system is indicated for premolar teeth.

Source page: https://510kreport.com/device/K203302
Methodology: https://510kreport.com/methodology