# K081268: Sonic Air MM1500 + (Mid), Model 50400014

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Mega Societe Anonyme
- Decided: Aug 10, 2009 after 462 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
No predicates in its family tree.
5 later devices descend from it; 3 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K130025: Sonendo Endotherapy System (2013), 3 descendants of its own
- 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
- K171150: AW-100 (2018), 0 descendants of its own

## Indications for use
Endodontics - canal preparation - canal cleaning

Source page: https://510kreport.com/device/K081268
Methodology: https://510kreport.com/methodology