Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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.
SONENDO, INC.
FG-003-00007
In Commercial Distribution

  • 00858395006202 ()
  • 00858395006219 ()
GW-APM-OMTX

  • Dental delivery system instrument unit, electric
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.
SONENDO, INC.
FG-001-00022
In Commercial Distribution

  • 00858395006189 ()
GW-MOL-PI01

  • Dental delivery system instrument unit, electric
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.
SONENDO, INC.
FG-001-00010
In Commercial Distribution

  • 00858395006080 ()
  • 00858395006158 ()
GW-MOL-SP10

  • Dental delivery system instrument unit, electric
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.
SONENDO, INC.
FG-001-00007
In Commercial Distribution

  • 00858395006059 ()
  • 00858395006127 ()
GW-MOL-SP07

  • Dental delivery system instrument unit, electric
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.
SONENDO, INC.
FG-001-00002
In Commercial Distribution

  • 00858395006028 ()
  • 00858395006172 ()
GW-MOL-DEPG

  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5 Pro+
In Commercial Distribution

  • 06944843655895 ()


  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5 Pro
In Commercial Distribution

  • 06944843655888 ()


  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5+
In Commercial Distribution

  • 06944843655871 ()


  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5
In Commercial Distribution

  • 06944843655864 ()


  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5 Pro+
In Commercial Distribution

  • 06944843655857 ()


  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5 Pro
In Commercial Distribution

  • 06944843655840 ()


  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5+
In Commercial Distribution

  • 06944843655833 ()


  • Dental delivery system instrument unit, electric
Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5
In Commercial Distribution

  • 06944843655826 ()


  • Dental delivery system instrument unit, electric
Dental delivery system instrument unit, electric
Guilin Woodpecker Medical Instrument Co., Ltd.
MT3
In Commercial Distribution

  • 06944843611563 ()


  • Dental delivery system instrument unit, electric
Dental delivery system instrument unit, electric
Guilin Woodpecker Medical Instrument Co., Ltd.
MT3
In Commercial Distribution

  • 06944843611518 ()


  • Dental delivery system instrument unit, electric
Dental delivery system instrument unit, electric
Guilin Woodpecker Medical Instrument Co., Ltd.
MT2
In Commercial Distribution

  • 06944843611488 ()


  • Dental delivery system instrument unit, electric
Dental delivery system instrument unit, electric
Guilin Woodpecker Medical Instrument Co., Ltd.
MT3
In Commercial Distribution

  • 06944843611259 ()


  • Dental delivery system instrument unit, electric
Dental delivery system instrument unit, electric
Guilin Woodpecker Medical Instrument Co., Ltd.
MT2
In Commercial Distribution

  • 06944843605395 ()


  • Dental delivery system instrument unit, electric
Dental delivery system instrument unit, electric
Guilin Woodpecker Medical Instrument Co., Ltd.
MT2
In Commercial Distribution

  • 06944843605173 ()


  • Dental delivery system instrument unit, electric
The Sensilight Pro is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured 6, 9 and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL300US04SNS
In Commercial Distribution

  • 05060445341576 ()


  • Intense pulsed light skin surface treatment system
The Sensilight Mini is an over the counter device intended for the removal of unwanted hair. The Sensilight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL030US05SNS
In Commercial Distribution

  • 05060445341569 ()


  • Intense pulsed light skin surface treatment system
The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL030US02SNS
In Commercial Distribution

  • 05060445340050 ()


  • Intense pulsed light skin surface treatment system
The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL030US01SNS
In Commercial Distribution

  • 05060445340043 ()


  • Intense pulsed light skin surface treatment system
The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL050US02SNS
In Commercial Distribution

  • 05060445340029 ()


  • Intense pulsed light skin surface treatment system
The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL050US03SNS
In Commercial Distribution

  • 05060445340012 ()


  • Intense pulsed light skin surface treatment system
The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL050US01SNS
In Commercial Distribution

  • 05060445340005 ()


  • Intense pulsed light skin surface treatment system
Multi-modality skin surface treatment system: Intense Pulsed Light (IPL).
Ellipse A/S
Sirius
In Commercial Distribution

  • 05713530000444 ()
9SYS7773

  • Intense pulsed light skin surface treatment system
Posterior CleanFlow Procedure Instrument with Matrices (Singles)
SONENDO, INC.
FG-013-00004
Not in Commercial Distribution

  • 00195893912278 ()
GW-PST-PI01

  • Dental delivery system instrument unit, electric
Intense Pulsed Light Skin Surface Treatment System
Strata Skin Sciences, Inc.
TC40
In Commercial Distribution

  • M709THCLR01 ()


  • Intense pulsed light skin surface treatment system
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-606-2.6
In Commercial Distribution

  • D104SAF60626 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-500-M4
In Commercial Distribution

  • D104SAF500M4 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-500-CART
In Commercial Distribution

  • D104SAF500CART0 ()
SAF-500-CART

  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-470
In Commercial Distribution

  • D104SAF470 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-430-2XP
In Commercial Distribution

  • D104SAF433XP0 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-430-2
In Commercial Distribution

  • D104SAF4303 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-430-2XP
In Commercial Distribution

  • D104SAF4302XP0 ()
SAF-430-2XP

  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-430-2
In Commercial Distribution

  • D104SAF4302 ()
SAF-430-2

  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-430
In Commercial Distribution

  • D104SAF430 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-606-4.6
In Commercial Distribution

  • D104SAF60646 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-531-Series II
In Commercial Distribution

  • D104SAF531SERIES2 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-500-M2
In Commercial Distribution

  • D104SAF500M2 ()


  • Dental delivery system instrument unit, electric
The Procenter Console Mounted Cuspidor is intended to provide water for oral rinsing, and a drain to dispose of waste water and oral debris during dental examinations.
MIDMARK CORPORATION
153603C
In Commercial Distribution

  • 00841709111839 ()
153603C

  • Dental delivery system instrument unit, electric
Midmark Procenter Rear Chair Hub Mounted (Midmark Elevance Chairs) Assistant's Unit Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.
MIDMARK CORPORATION
153604LR-E
In Commercial Distribution

  • 00841709110382 ()
153604LR-E

  • Dental delivery system instrument unit, electric
Midmark Procenter LR Concept (Midmark Ultra Chairs) Cuspidor and Assistant's Combination Unit Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.
MIDMARK CORPORATION
153604LRCA
In Commercial Distribution

  • 00841709110368 ()
153604LRCA

  • Dental delivery system instrument unit, electric
Midmark Procenter Console Mounted Assistant's Unit Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.
MIDMARK CORPORATION
153604CE
In Commercial Distribution

  • 00841709110344 ()
153604CE

  • Dental delivery system instrument unit, electric
The Procenter Concept LR Mounted Cuspidor is intended to provide water for oral rinsing, and a drain to dispose of waste water and oral debris during dental examinations.
MIDMARK CORPORATION
153603LR
In Commercial Distribution

  • 00841709110320 ()
153603LR

  • Dental delivery system instrument unit, electric
Midmark Asepsis 21 L/R Duo Cart Delivery Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.
MIDMARK CORPORATION
153740-003
In Commercial Distribution

  • 00841709110177 ()
153740-003

  • Dental delivery system instrument unit, electric
Midmark Asepsis 21 Doctor's Cart Delivery Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.
MIDMARK CORPORATION
153740-002
In Commercial Distribution

  • 00841709110160 ()
153740-002

  • Dental delivery system instrument unit, electric
Midmark Asepsis 21 Assistant's Cart Delivery Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.
MIDMARK CORPORATION
153740-001
In Commercial Distribution

  • 00841709110153 ()
153740-001

  • Dental delivery system instrument unit, electric
Midmark Doctor's 2 Handpiece Control with Syringe and Assistant's HVE and Saliva Ejector Cabinet Mounted Instrument Delivery Systems are intended to provide dental professionals with air, suction and water to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.
MIDMARK CORPORATION
153839-003
In Commercial Distribution

  • 00841709110139 ()
153839-003

  • Dental delivery system instrument unit, electric
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