# Sonendo, Inc.

- Location (FDA's records): Laguna Hills, CA
- FDA decisions: 9 (2013–2021): 9 510(k) clearances
- Product codes: ELC (7), KIF (2)
- 510(k) review time since 2016: median 76 days, against 118 for FDA's reviews in the same codes and years (5 of 6 faster)
- Predicates its devices cite: 11 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- E.M.S Electro Medical Systems S.A: 2 (https://510kreport.com/company/ems-electro-medical-systems-s-a)
- Micro-Mega Societe Anonyme: 2 (https://510kreport.com/company/micro-mega-societe-anonyme)
- Innovative Bioceramix, Inc.: 1 (https://510kreport.com/company/innovative-bioceramix)
- Ultradent Products, Inc.: 1 (https://510kreport.com/company/ultradent-products)

## Firms that cite its devices most
- Lumendo AG: 1 (https://510kreport.com/company/lumendo)
- Odne AG: 1 (https://510kreport.com/company/odne)

## Its most-cited devices
- K160905: Sonendo GentleWave System (2016), cited by 2
- K153157: Sonendo Gentle Wave System (2016), cited by 1
- K133752: Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure Kit (2014), cited by 1
- K130025: Sonendo Endotherapy System (2013), cited by 1
- K211995: Sonendo Filling Material 5C (2021), cited by 1
- K143448: Sonendo GentleWave System (2015), cited by 1

## Recent decisions
- K211995: Sonendo Filling Material 5C (Aug 27, 2021)
- K203302: GentleWave X (Feb 5, 2021)
- K190359: Sonendo GentleWave System (Mar 16, 2019)
- K181922: Sonendo Material A (Oct 22, 2018)
- K160905: Sonendo GentleWave System (Jun 3, 2016)
- K153157: Sonendo Gentle Wave System (Jan 29, 2016)
- K143448: Sonendo GentleWave System (May 1, 2015)
- K133752: Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure Kit (May 15, 2014)

Source page: https://510kreport.com/company/sonendo