# K133752: Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sonendo, Inc.
- Decided: May 15, 2014 after 157 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 K081268 (2009). 3 ancestors in all.
2 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)
- K130025: Sonendo Endotherapy System, Sonendo, Inc. (2013) Summary page 1.
- 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 2.

## Most influential descendants
- K143448: Sonendo GentleWave System (2015), 1 descendant of its own
- K233844: OdneClean (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K133752
Methodology: https://510kreport.com/methodology