# K130025: Sonendo Endotherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Sonendo, Inc.
- Decided: Jun 11, 2013 after 159 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: 1 generation back to K081268 (2009). 2 ancestors in all.
3 later devices descend 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)
- K093000: Ems Piezon Master 700, E.M.S Electro Medical Systems S.A (2010) Summary page 1.
- K081268: Sonic Air MM1500 + (Mid), Model 50400014, Micro-Mega Societe Anonyme (2009) Summary page 1.

## Most influential descendants
- K133752: Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure Kit (2014), 2 descendants of its own
- K143448: Sonendo GentleWave System (2015), 1 descendant of its own
- K233844: OdneClean (2024), 0 descendants of its own

## Indications for use
The Sonendo Endotherapy System is intended to prepare, clean and irrigate 1* and 2™ molar teeth indicated for root canal therapy.

Source page: https://510kreport.com/device/K130025
Methodology: https://510kreport.com/methodology