Address:26061 Merit Circle,Laguna Hills,CA,92653,US
Device Description : The Molar Procedure Instrument, when used with the GentleWave Console, is intend The Molar Procedure Instrument, when used with the 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 procedure site.
Device Class : 2
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
Device Description : Used to gauge the depth of the pulp chamber. Depth Gauges help determine the pro Used to gauge the depth of the pulp chamber. Depth Gauges help determine the proper Sealing Cap needed to prepare the Molar Procedure Instrument for procedure.
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 : Sonendo EDTA is a 17% EDTA chelating agent used for debriding and clearing the r Sonendo EDTA is a 17% EDTA chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin.
Device Class : 1
Duns Number: 828894373
Premarket Exempt : No
Prescription Use : Yes