Address:26061 Merit Circle,Laguna Hills,CA,92653,US
Device Description : The Molar Procedure Instrument, when used with the Sonendo GentleWave Console, i The Molar Procedure Instrument, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
Device Class : 2
Duns Number: 828894373
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Anterior/Premolar Procedure Instrument, when used with the GentleWave Consol The Anterior/Premolar Procedure Instrument, when used with the GentleWave Console, is intended to be used on the anterior or premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the procedure site.
Device Class : 2
Duns Number: 828894373
Premarket Exempt : No
Prescription Use : Yes
Device Description : The APM Matrix is used to form a flat surface on the occlusal surface of a tooth The APM Matrix is used to form a flat surface on the occlusal surface of a tooth by spreading a bite registration material into the surface irregularities of the crown.
Device Class :
Duns Number: 828894373
Premarket Exempt : No
Prescription Use : Yes
Device Description : The GentleWave Console is a semi-stationary unit designed to prepare and deliver The GentleWave Console is a semi-stationary unit designed to prepare and deliver a procedure fluid to the Anterior/Premolar or Molar Procedure Instruments. The Procedure Instruments are used to deliver the procedure fluid to the selected anterior or premolar tooth when used with the Anterior/Premolar Procedure Instrument and the selected molar tooth when used with the Molar Procedure Instrument.
Device Class : 2
Duns Number: 828894373
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Anterior/Premolar Procedure Instrument with Matrix, when used with the Gentl The Anterior/Premolar Procedure Instrument with Matrix, when used with the GentleWave Console, is intended to be used on the anterior or premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the procedure site.
Device Class :
Duns Number: 828894373
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Molar Procedure Instrument with Accessories, when used with the Sonendo Gent The Molar Procedure Instrument with Accessories, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
Device Class :
Duns Number: 828894373
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Molar Treatment Instrument, when used with the Sonendo GentleWave Console, i The Molar Treatment Instrument, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
Device Class : 2
Duns Number: 828894373
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Anterior/Premolar Procedure Instrument with Matrix, when used with the Gentl The Anterior/Premolar Procedure Instrument with Matrix, when used with the GentleWave Console, is intended to be used on the anterior or premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the procedure site.
Device Class : 2
Duns Number: 828894373
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Anterior/Premolar Procedure Instrument with Matrix, when used with the Gentl The Anterior/Premolar Procedure Instrument with Matrix, when used with the GentleWave Console, is intended to be used on the anterior or premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the procedure site.
Device Class :
Duns Number: 828894373
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Anterior/Premolar Procedure Instrument with Matrix, when used with the Gentl The Anterior/Premolar Procedure Instrument with Matrix, when used with the GentleWave Console, is intended to be used on the anterior or premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the procedure site.
Device Class : 2
Duns Number: 828894373
Premarket Exempt : No
Prescription Use : Yes