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 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 : Power bleaching: SoundSeal is used to protect the gingival during power bleachi Power bleaching: SoundSeal is used to protect the gingival during power bleaching procedures.Block-out resin: SoundSeal is used to block out undercuts and gingival embrasures prior to taking impressions for crowns and bridges.Sandblasting: SoundSeal is used to mask and protect the gingiva during sandblasting. It is also placed on the areas of teeth to be masked during the sandblasting process.
Device Class :
Duns Number: 828894373
Premarket Exempt : No
Prescription Use : Yes
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
Prescription Use : Yes
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
Prescription Use : Yes
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
Prescription Use : Yes
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
Prescription Use : Yes
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
Prescription Use : Yes
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
Prescription Use : Yes
Device Description : The Molar Matrix is used to form a flat surface on the occlusal surface of a too The Molar 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