SONENDO, INC.

Address:26061 Merit Circle,Laguna Hills,CA,92653,US

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- Catalog Number : GW-APM-OMTX

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

Product Code : ELC

Prescription Use : Yes

Device Count : 10

Device Description : Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo GentleWave Console, is intended to be used on the 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 treatment site.

Device Class : 2

Duns Number: 828894373

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 10

Device Description : The Premolar CrossFire Procedure Instrument with Matrix, when used with the Sone The Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo GentleWave Console, is intended to be used on 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 treatment site.

Device Class : 2

Duns Number: 828894373

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

- Catalog Number : GW-MOL-SC05

Device Description : Sealing Caps attach to the Molar Procedure Instrument in order to properly setup Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.

Device Class :

Duns Number: 828894373

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 10

- Catalog Number : GW-MOL-SC06

Device Description : Sealing Caps attach to the Molar Procedure Instrument in order to properly setup Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.

Device Class :

Duns Number: 828894373

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 10

- Catalog Number : GW-MOL-SC07

Device Description : Sealing Caps attach to the Molar Procedure Instrument in order to properly setup Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.

Device Class :

Duns Number: 828894373

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 10

- Catalog Number : GW-MOL-SC08

Device Description : Sealing Caps attach to the Molar Procedure Instrument in order to properly setup Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.

Device Class :

Duns Number: 828894373

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 10

- Catalog Number : GW-MOL-SP09

Device Description : Sealing Caps attach to the Molar Procedure Instrument in order to properly setup Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.

Device Class :

Duns Number: 828894373

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 10