Manufacturer registered with FDA
Sonendo, Inc.
Laguna Hills, CA, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 9 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 2
- 510(k) clearances
- 92013–2021
- Markets registered in
- 216 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Sonendo, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Sonendo, Inc. | 9 clearances | 2013–2021 | Below |
| Canada | Health Canada | Registration holder | SONENDO, INC. | 16 | 2018–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Sonendo, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | GentleWave System | 2019 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Ergo Arm | 2018 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | — | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Sonendo, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Aug 2021 | K211995 | Sonendo Filling Material 5C | KIF Root Canal Filling Resin |
| 5 Feb 2021 | K203302 | GentleWave X | ELC Ultrasonic Scaler |
| 16 Mar 2019 | K190359 | Sonendo GentleWave System | ELC Ultrasonic Scaler |
| 22 Oct 2018 | K181922 | Sonendo Material A | KIF Root Canal Filling Resin |
| 3 Jun 2016 | K160905 | Sonendo GentleWave System | ELC Ultrasonic Scaler |
| 29 Jan 2016 | K153157 | Sonendo Gentle Wave System | ELC Ultrasonic Scaler |
| 1 May 2015 | K143448 | Sonendo GentleWave System | ELC Ultrasonic Scaler |
| 15 May 2014 | K133752 | SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT | ELC Ultrasonic Scaler |
| 11 Jun 2013 | K130025 | SONENDO ENDOTHERAPY SYSTEM | ELC Ultrasonic Scaler |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SONENDO, INC.FDA reg. 3010817521 | Laguna Hills, CA, United States | Complaint file establishment, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046931). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.