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Sign in to claim this brandSONENDO, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 26061 Merit Circle, Laguna Hills, CA, 92653
- Website
- sonendo.com
- —
- —
- [email protected]
- Phone
- 8447663636
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3010817521
- DUNS Number
- 828894373
Catalogue (54)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GentleWave G4 Console | FG-012-00001 | FDA UDI | Class II | Active |
| GentleWave G4 Console | FG-012-00005 | FDA UDI | Class II | Active |
| Sealing Cap (Size 6) | FG-001-00106 | FDA UDI | Class II | Active |
| Sealing Cap (Size 5) | FG-001-00005 | FDA UDI | Class II | Active |
| Sealing Cap (Size 10) | FG-001-00010 | FDA UDI | Class II | Active |
| Molar Procedure Instrument with Accessories | FG-001-00020 | FDA UDI | Class II | Active |
| Molar Procedure Instrument with Accessories | FG-001-00025 | FDA UDI | Class II | Active |
| Sealing Cap (Size 8) | FG-001-00008 | FDA UDI | Class II | Active |
| Sealing Cap (Size 7) | FG-001-00007 | FDA UDI | Class II | Active |
| APM Matrix | FG-003-00007 | FDA UDI | Class II | Active |
| Sealing Cap (Size 9) | FG-001-00109 | FDA UDI | Class II | Active |
| Sealing Cap (Size 8) | FG-001-00108 | FDA UDI | Class II | Active |
| Sealing Cap (Size 6) | FG-001-00006 | FDA UDI | Class II | Active |
| Premolar CrossFire Procedure Instrument with Matrix | FG-014-00003 | FDA UDI | Class II | Active |
| Premolar CrossFire Procedure Instrument with Matrix | FG-014-00001 | FDA UDI | Class II | Active |
| Molar Procedure Instrument | FG-001-00019 | FDA UDI | Class II | Unknown |
| Sealing Cap (Size 7) | FG-001-00107 | FDA UDI | Class II | Active |
| Molar Matrix | FG-001-00003 | FDA UDI | Class II | Active |
| Sealing Cap (Size 9) | FG-001-00009 | FDA UDI | Class II | Active |
| Molar Procedure Instrument with Accessories | FG-001-00023 | FDA UDI | Class II | Active |
| SoundSeal | FG-008-00002 | FDA UDI | Class I | Active |
| Molar Matrix | FG-001-00003 | FDA UDI | Class II | Active |
| Sealing Cap (Size 8) | FG-001-00008 | FDA UDI | Class II | Active |
| Molar Treatment Instrument | FG-001-00001 | FDA UDI | Class II | Unknown |
| Sonendo 17% EDTA | FG-008-00001 | FDA UDI | Class I | Active |
| Anterior/Premolar Procedure Instrument | FG-003-00002 | FDA UDI | Class II | Unknown |
| Sealing Cap (Size 9) | FG-001-00009 | FDA UDI | Class II | Active |
| Sealing Cap (Size 5) | FG-001-00005 | FDA UDI | Class II | Active |
| APM Procedure Instrument with Matrix | FG-003-00009 | FDA UDI | Class II | Unknown |
| Sealing Cap (Size 5) | FG-001-00105 | FDA UDI | Class II | Active |
| APM Procedure Instrument with Matrix | FG-003-00011 | FDA UDI | Class II | Active |
| Posterior CleanFlow Procedure Instrument with Matrices | FG-013-00004 | FDA UDI | Class II | Unknown |
| Depth Gauges | FG-001-00002 | FDA UDI | Class II | Active |
| Posterior CleanFlow Procedure Instrument with Matrix | FG-013-00004 | FDA UDI | Class II | Active |
| APM Procedure Instrument with Matrix | FG-003-00008 | FDA UDI | Class II | Unknown |
| GentleWave Console | FG-002-00001 | FDA UDI | Class II | Active |
| Molar Procedure Instrument with Accessories | FG-001-00022 | FDA UDI | Class II | Active |
| Sealing Cap (Size 10) | FG-001-00010 | FDA UDI | Class II | Active |
| APM Matrix | FG-003-00007 | FDA UDI | Class II | Active |
| Posterior Cleanflow Matrices | FG-013-00007 | FDA UDI | Class II | Active |
| Posterior CleanFlow Procedure Instrument with Matrices | FG-013-00003 | FDA UDI | Class II | Active |
| GentleWave G4 Support Arm | FG-012-00002 | FDA UDI | Class I | Active |
| Sealing Cap (Size 7) | FG-001-00007 | FDA UDI | Class II | Active |
| Sealing Cap (Size 6) | FG-001-00006 | FDA UDI | Class II | Active |
| APM Procedure Instrument with Matrix | FG-003-00010 | FDA UDI | Class II | Active |
| Sonendo GentleWave System | K160905 | FDA 510(k) | Class II | Active |
| Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure Kit | K133752 | FDA 510(k) | Class II | Active |
| Sonendo Material A | K181922 | FDA 510(k) | Class II | Active |
| Sonendo GentleWave System | K143448 | FDA 510(k) | Class II | Active |
| Sonendo GentleWave System | K190359 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 14, 2022 | Z-0234-2023 | — | open, classified | Procedure Instruments with erroneous unit carton labels. |
| Oct 14, 2022 | Z-0233-2023 | — | open, classified | Procedure Instruments with erroneous unit carton labels. |
| Oct 23, 2019 | Z-2162-2020 | — | terminated | The console would continue to run for extended period when the foot pedal was released. |