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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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Dentacenter Operative Dental Unit - D104SAF4302XP0

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

Dentacenter Operative Dental Unit - D104SAF4302

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

Sensilight Pro - bronze - 05060445341576

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

Sensilight Mini - bronze - 05060445341569

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

SensiLight Mini - blue - 05060445340050

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

SensiLight Mini - mint - 05060445340043

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

SensiLight - salmon - 05060445340029

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

SensiLight - mint - 05060445340012

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

SensiLight - grey - 05060445340005

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

A-dec - 10194665007300

A-dec CART343pro Cart Delivery System
A-DEC, INC.
343pro
In Commercial Distribution

  • 10194665007300 ()
343pro

  • Dental delivery system instrument unit, electric

I-UNICELL Incubator - 06925912711049

No Description
Shenzhen YHLO Biotech Co., Ltd.
I-UNICELL
In Commercial Distribution

  • 06925912711049 ()
I6101

  • Microplate/tube/assay card incubator IVD

GSD - 06928258000891

No Description
Shenzhen GSD Tech Co., Ltd.
GP666C4
In Commercial Distribution

  • 06928258000891 ()


  • Intense pulsed light skin surface treatment system

DTE - 06944843655895

Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5 Pro+
In Commercial Distribution

  • 06944843655895 ()


  • Dental delivery system instrument unit, electric

DTE - 06944843655888

Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5 Pro
In Commercial Distribution

  • 06944843655888 ()


  • Dental delivery system instrument unit, electric

DTE - 06944843655871

Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5+
In Commercial Distribution

  • 06944843655871 ()


  • Dental delivery system instrument unit, electric

DTE - 06944843655864

Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5
In Commercial Distribution

  • 06944843655864 ()


  • Dental delivery system instrument unit, electric

woodpecker - 06944843655857

Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5 Pro+
In Commercial Distribution

  • 06944843655857 ()


  • Dental delivery system instrument unit, electric

woodpecker - 06944843655840

Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5 Pro
In Commercial Distribution

  • 06944843655840 ()


  • Dental delivery system instrument unit, electric

woodpecker - 06944843655833

Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5+
In Commercial Distribution

  • 06944843655833 ()


  • Dental delivery system instrument unit, electric

woodpecker - 06944843655826

Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd.
ES5
In Commercial Distribution

  • 06944843655826 ()


  • Dental delivery system instrument unit, electric

DTE - 06944843611563

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

  • 06944843611563 ()


  • Dental delivery system instrument unit, electric

WOODPECKER - 06944843611518

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

  • 06944843611518 ()


  • Dental delivery system instrument unit, electric

DBA - 06944843611488

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

  • 06944843611488 ()


  • Dental delivery system instrument unit, electric

DTE,WOODPECKER - 06944843611259

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

  • 06944843611259 ()


  • Dental delivery system instrument unit, electric

DTE - 06944843605395

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

  • 06944843605395 ()


  • Dental delivery system instrument unit, electric

WOODPECKER - 06944843605173

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

  • 06944843605173 ()


  • Dental delivery system instrument unit, electric

Ellipse - 05713530000444

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

Beurer - 00852547004733

Light based, over the counter device intended for the removal of unwanted hair as well as permanent reduction in hair regrowth.
BEURER NORTH AMERICA, L.P.
IPL7500 (Art.-No. 575.71)
In Commercial Distribution

  • 10852547004730 ()
  • 00852547004733 ()


  • Intense pulsed light skin surface treatment system

Vitalcontrol - 00852547004498

Light based, over the counter device intended for the removal of unwanted hair as well as permanent reduction in hair regrowth.
BEURER NORTH AMERICA, L.P.
IPL100 (Art.-No. 575.40)
In Commercial Distribution

  • 10852547004495 ()
  • 00852547004498 ()
Art.-No. 575.40

  • Intense pulsed light skin surface treatment system

APM Matrix - 00858395006455

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

  • 00858395006455 ()
  • 00858395006219 ()
GW-APM-OMTX

  • Dental delivery system instrument unit, electric

Molar Matrix - 00858395006448

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.
SONENDO, INC.
FG-001-00003
In Commercial Distribution

  • 00858395006448 ()
  • 00858395006165 ()
GW-MOL-OMTX

  • Dental delivery system instrument unit, electric

Sealing Cap (Size 10) - 00858395006424

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

  • 00858395006424 ()
  • 00858395006158 ()
GW-MOL-SP10

  • Dental delivery system instrument unit, electric

Sealing Cap (Size 9) - 00858395006417

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-001-00009
In Commercial Distribution

  • 00858395006417 ()
  • 00858395006141 ()
GW-MOL-SP09

  • Dental delivery system instrument unit, electric

Sealing Cap (Size 8) - 00858395006400

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-001-00008
In Commercial Distribution

  • 00858395006400 ()
  • 00858395006134 ()
GW-MOL-SP08

  • Dental delivery system instrument unit, electric

Sealing Cap (Size 7) - 00858395006394

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

  • 00858395006394 ()
  • 00858395006127 ()
GW-MOL-SP07

  • Dental delivery system instrument unit, electric

Sealing Cap (Size 6) - 00858395006387

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-001-00006
In Commercial Distribution

  • 00858395006387 ()
  • 00858395006110 ()
GW-MOL-SP06

  • Dental delivery system instrument unit, electric

Sealing Cap (Size 5) - 00858395006370

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-001-00005
In Commercial Distribution

  • 00858395006370 ()
  • 00858395006103 ()
GW-MOL-SP05

  • Dental delivery system instrument unit, electric

Molar Procedure Instrument with Accessories - 00858395006332

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.
SONENDO, INC.
FG-001-00025
In Commercial Distribution

  • 00858395006332 ()
  • 00858395006349 ()
GW-MOL-PI10

  • Dental delivery system instrument unit, electric

Molar Procedure Instrument with Accessories - 00858395006325

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-001-00023
In Commercial Distribution

  • 00858395006325 ()
GW-MOL-PI01

  • Dental delivery system instrument unit, electric

APM Procedure Instrument with Matrix - 00858395006318

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.
SONENDO, INC.
FG-003-00011
In Commercial Distribution

  • 00858395006318 ()
GW-APM-PI01

  • Dental delivery system instrument unit, electric

APM Procedure Instrument with Matrix - 00858395006295

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.
SONENDO, INC.
FG-003-00010
In Commercial Distribution

  • 00858395006295 ()
  • 00858395006301 ()
GW-APM-PI10

  • Dental delivery system instrument unit, electric

APM Procedure Instrument with Matrix - 00858395006288

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.
SONENDO, INC.
FG-003-00009
Not in Commercial Distribution

  • 00858395006288 ()
GW-APM-PI01

  • Dental delivery system instrument unit, electric

Molar Treatment Instrument - 00858395006271

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.
SONENDO, INC.
FG-001-00001
Not in Commercial Distribution

  • 00858395006271 ()
GW-MOL-TIXX

  • Dental delivery system instrument unit, electric

Molar Procedure Instrument with Accessories - 00858395006257

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.
SONENDO, INC.
FG-001-00020
In Commercial Distribution

  • 00858395006257 ()
  • 00858395006264 ()
GW-MOL-PI10

  • Dental delivery system instrument unit, electric

APM Procedure Instrument with Matrix - 00858395006240

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.
SONENDO, INC.
FG-003-00008
Not in Commercial Distribution

  • 00858395006240 ()
  • 00858395006233 ()
GW-APM-PI10

  • Dental delivery system instrument unit, electric

GentleWave Console - 00858395006226

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.
SONENDO, INC.
FG-002-00001
In Commercial Distribution

  • 00858395006226 ()


  • Dental delivery system instrument unit, electric

APM Matrix - 00858395006202

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

Anterior/Premolar Procedure Instrument - 00858395006196

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.
SONENDO, INC.
FG-003-00002
Not in Commercial Distribution

  • 00858395006196 ()
GW-APM-TIXX

  • Dental delivery system instrument unit, electric

Molar Procedure Instrument with Accessories - 00858395006189

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 Cap (Size 10) - 00858395006080

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
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