This page includes the latest FDA filings for Sonendo Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3010817521 |
| FEI Number | 3010817521 |
| Name | SONENDO, INC. |
| Owner & Operator | Sonendo, Inc. |
| Contact Address | 26061 Merit Circle Suite 101 Laguna Hills CA 92653 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 26061 Merit Circle Suite 101 Laguna Hills, CA 92653 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| SONENDO, INC. | GentleWave G4 Console | 2023-07-19 |
| SONENDO, INC. | Posterior CleanFlow Procedure Instrument with Matrix GW-PST-PI01 | 2023-05-04 |
| SONENDO, INC. | GentleWave G4 Support Arm GW-ARM-0001 | 2023-05-04 |
| SONENDO, INC. | Posterior Cleanflow Matrices GW-PST-OMTX | 2022-11-02 |
| SONENDO, INC. | Posterior CleanFlow Procedure Instrument with Matrices GW-PST-PI10 | 2022-11-02 |
| SONENDO, INC. | GentleWave G4 Console GW-CON-0400 | 2022-11-02 |
| SONENDO, INC. | Posterior CleanFlow Procedure Instrument with Matrices GW-PST-PI01 | 2022-11-02 |
Sonendo, Inc. | Sonendo Filling Material 5C | 2021-08-27 |
Sonendo, Inc | GentleWave X | 2021-02-05 |
| SONENDO, INC. | Premolar CrossFire Procedure Instrument with Matrix GW-PRE-XF01 | 2020-10-28 |
| SONENDO, INC. | Premolar CrossFire Procedure Instrument with Matrix GW-PRE-XF10 | 2020-10-28 |
SONENDO, INC. | GentleWave System | 2019-05-20 |
| SONENDO, INC. | APM Procedure Instrument with Matrix GW-APM-PI01 | 2019-05-17 |
| SONENDO, INC. | APM Procedure Instrument with Matrix GW-APM-PI10 | 2019-05-17 |
| SONENDO, INC. | Anterior/Premolar Procedure Instrument GW-APM-TIXX | 2019-05-17 |
| SONENDO, INC. | Molar Procedure Instrument GW-MOL-TIXX | 2019-05-17 |
Sonendo, Inc. | Sonendo GentleWave System | 2019-03-16 |
Sonendo, Inc. | Sonendo Material A | 2018-10-22 |
| SONENDO, INC. | SoundSeal GW-SYS-SOSE | 2018-07-06 |
| SONENDO, INC. | Sonendo 17% EDTA GW-SYS-EDTA | 2018-07-06 |
| SONENDO, INC. | APM Matrix GW-APM-OMTX | 2018-05-25 |
| SONENDO, INC. | Molar Matrix GW-MOL-OMTX | 2018-05-25 |
| SONENDO, INC. | Sealing Cap (Size 10) GW-MOL-SP10 | 2018-05-25 |
| SONENDO, INC. | Sealing Cap (Size 9) GW-MOL-SP09 | 2018-05-25 |
| SONENDO, INC. | Sealing Cap (Size 8) GW-MOL-SP08 | 2018-05-25 |
| SONENDO, INC. | Sealing Cap (Size 7) GW-MOL-SP07 | 2018-05-25 |
| SONENDO, INC. | Sealing Cap (Size 6) GW-MOL-SP06 | 2018-05-25 |
| SONENDO, INC. | Sealing Cap (Size 5) GW-MOL-SP05 | 2018-05-25 |
| SONENDO, INC. | APM Procedure Instrument with Matrix GW-APM-PI01 | 2018-05-25 |
| SONENDO, INC. | APM Procedure Instrument with Matrix GW-APM-PI10 | 2018-05-25 |
| SONENDO, INC. | Molar Procedure Instrument with Accessories GW-MOL-PI10 | 2018-04-30 |
| SONENDO, INC. | Molar Procedure Instrument with Accessories GW-MOL-PI01 | 2018-04-30 |
| SONENDO, INC. | Molar Treatment Instrument GW-MOL-TIXX | 2018-03-29 |
| SONENDO, INC. | Molar Procedure Instrument with Accessories GW-MOL-PI10 | 2018-03-29 |
| SONENDO, INC. | GentleWave Console | 2018-03-29 |
| SONENDO, INC. | APM Matrix GW-APM-OMTX | 2018-03-29 |
| SONENDO, INC. | Molar Procedure Instrument with Accessories GW-MOL-PI01 | 2018-03-29 |
| SONENDO, INC. | Sealing Cap (Size 10) GW-MOL-SP10 | 2018-03-29 |
| SONENDO, INC. | Sealing Cap (Size 9) GW-MOL-SP09 | 2018-03-29 |
| SONENDO, INC. | Sealing Cap (Size 8) GW-MOL-SP08 | 2018-03-29 |
| SONENDO, INC. | Sealing Cap (Size 7) GW-MOL-SP07 | 2018-03-29 |
| SONENDO, INC. | Sealing Cap (Size 6) GW-MOL-SP06 | 2018-03-29 |
| SONENDO, INC. | Sealing Cap (Size 5) GW-MOL-SP05 | 2018-03-29 |
| SONENDO, INC. | Depth Gauges GW-MOL-DEPG | 2018-03-29 |
| SONENDO, INC. | Molar Matrix GW-MOL-OMTX | 2018-03-29 |
SONENDO, INC. | Ergo Arm | 2018-02-07 |
SONENDO, INC. | Sonendo GentleWave System | 2016-06-03 |
SONENDO, INC. | Sonendo Gentle Wave System | 2016-01-29 |
Sonendo, Inc. | Sonendo GentleWave System | 2015-05-01 |
SONENDO, INC. | SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT | 2014-05-15 |
SONENDO, INC. | SONENDO ENDOTHERAPY SYSTEM | 2013-06-11 |
| SEC | 0001407973 | Sonendo, Inc. of DELAWARE |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020022940333 | Kaohsiung,China (Taiwan) -> Los Angeles, California | PLASTIC BOTTLEINVOICE NO113428 EYTHS CODE 392690 | 75 CTN |
| 2019080146082 | Kaohsiung,China (Taiwan) -> Los Angeles, California | PLASTIC BOTTLEINVOICE NO106474 EYTHS CODE 901890 | 50 CTN |