Sonendo Inc

FDA Filings

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.

FDA Registration(s)
Registration Number3010817521
FEI Number3010817521
NameSONENDO, INC.
Owner & OperatorSonendo, Inc.
Contact Address26061 Merit Circle Suite 101
Laguna Hills CA 92653 US
Official Correspondent
  • Jane Metcalf
  • 1-949-7663636-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address26061 Merit Circle Suite 101
Laguna Hills, CA 92653 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Sonendo, Inc
GentleWave X2021-02-05
SONENDO, INC.
Premolar CrossFire Procedure Instrument with Matrix GW-PRE-XF012020-10-28
SONENDO, INC.
Premolar CrossFire Procedure Instrument with Matrix GW-PRE-XF102020-10-28
SONENDO, INC.
GentleWave System2019-05-20
SONENDO, INC.
APM Procedure Instrument with Matrix GW-APM-PI012019-05-17
SONENDO, INC.
APM Procedure Instrument with Matrix GW-APM-PI102019-05-17
SONENDO, INC.
Anterior/Premolar Procedure Instrument GW-APM-TIXX2019-05-17
SONENDO, INC.
Molar Procedure Instrument GW-MOL-TIXX2019-05-17
Sonendo, Inc.
Sonendo GentleWave System2019-03-16
Sonendo, Inc.
Sonendo Material A2018-10-22
SONENDO, INC.
SoundSeal GW-SYS-SOSE2018-07-06
SONENDO, INC.
Sonendo 17% EDTA GW-SYS-EDTA2018-07-06
SONENDO, INC.
APM Matrix GW-APM-OMTX2018-05-25
SONENDO, INC.
Molar Matrix GW-MOL-OMTX2018-05-25
SONENDO, INC.
Sealing Cap (Size 10) GW-MOL-SP102018-05-25
SONENDO, INC.
Sealing Cap (Size 9) GW-MOL-SP092018-05-25
SONENDO, INC.
Sealing Cap (Size 8) GW-MOL-SP082018-05-25
SONENDO, INC.
Sealing Cap (Size 7) GW-MOL-SP072018-05-25
SONENDO, INC.
Sealing Cap (Size 6) GW-MOL-SP062018-05-25
SONENDO, INC.
Sealing Cap (Size 5) GW-MOL-SP052018-05-25
SONENDO, INC.
APM Procedure Instrument with Matrix GW-APM-PI012018-05-25
SONENDO, INC.
APM Procedure Instrument with Matrix GW-APM-PI102018-05-25
SONENDO, INC.
Molar Procedure Instrument with Accessories GW-MOL-PI102018-04-30
SONENDO, INC.
Molar Procedure Instrument with Accessories GW-MOL-PI012018-04-30
SONENDO, INC.
Molar Treatment Instrument GW-MOL-TIXX2018-03-29
SONENDO, INC.
Molar Procedure Instrument with Accessories GW-MOL-PI102018-03-29
SONENDO, INC.
GentleWave Console 2018-03-29
SONENDO, INC.
APM Matrix GW-APM-OMTX2018-03-29
SONENDO, INC.
Molar Procedure Instrument with Accessories GW-MOL-PI012018-03-29
SONENDO, INC.
Sealing Cap (Size 10) GW-MOL-SP102018-03-29
SONENDO, INC.
Sealing Cap (Size 9) GW-MOL-SP092018-03-29
SONENDO, INC.
Sealing Cap (Size 8) GW-MOL-SP082018-03-29
SONENDO, INC.
Sealing Cap (Size 7) GW-MOL-SP072018-03-29
SONENDO, INC.
Sealing Cap (Size 6) GW-MOL-SP062018-03-29
SONENDO, INC.
Sealing Cap (Size 5) GW-MOL-SP052018-03-29
SONENDO, INC.
Depth Gauges GW-MOL-DEPG2018-03-29
SONENDO, INC.
Molar Matrix GW-MOL-OMTX2018-03-29
SONENDO, INC.
Ergo Arm2018-02-07
SONENDO, INC.
Sonendo GentleWave System2016-06-03
SONENDO, INC.
Sonendo Gentle Wave System2016-01-29
Sonendo, Inc.
Sonendo GentleWave System2015-05-01
SONENDO, INC.
SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT2014-05-15
SONENDO, INC.
SONENDO ENDOTHERAPY SYSTEM2013-06-11

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020022940333Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaPLASTIC BOTTLEINVOICE NO113428 EYTHS CODE 39269075 CTN
2019080146082Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaPLASTIC BOTTLEINVOICE NO106474 EYTHS CODE 90189050 CTN

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