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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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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

Sealing Cap (Size 7) - 00858395006059

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

Depth Gauges - 00858395006028

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

Molar Matrix - 00858395006011

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

  • 00858395006011 ()
  • 00858395006165 ()
GW-MOL-OMTX

  • Dental delivery system instrument unit, electric

Molar Procedure Instrument - 00858395006004

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.
SONENDO, INC.
FG-001-00019
Not in Commercial Distribution

  • 00858395006004 ()
GW-MOL-TIXX

  • Dental delivery system instrument unit, electric

Posterior CleanFlow Procedure Instrument with Matrix - 00858395006783

CleanFlow Device used with the GentleWave System to treat root canals (Posterior teeth).
SONENDO, INC.
FG-013-00004
In Commercial Distribution

  • 00858395006783 ()
GW-PST-PI01

  • Dental delivery system instrument unit, electric

GentleWave G4 Console - 00858395006776

GentleWave G4 Console
SONENDO, INC.
FG-012-00005
In Commercial Distribution

  • 00858395006776 ()


  • Dental delivery system instrument unit, electric

Posterior Cleanflow Matrices - 00858395006738

Posterior Cleanflow Matrices (10 Pack)
SONENDO, INC.
FG-013-00007
In Commercial Distribution

  • 00858395006745 ()
  • 00858395006738 ()
GW-PST-OMTX

  • Dental delivery system instrument unit, electric

Premolar CrossFire Procedure Instrument with Matrix - 00858395006653

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.
SONENDO, INC.
FG-014-00001
In Commercial Distribution

  • 00858395006646 ()
  • 00858395006653 ()
GW-PRE-XF10

  • Dental delivery system instrument unit, electric

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 9) - 00858395006073

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

  • 00858395006073 ()
  • 00858395006141 ()
GW-MOL-SP09

  • Dental delivery system instrument unit, electric

Sealing Cap (Size 8) - 00858395006066

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

  • 00858395006066 ()
  • 00858395006134 ()
GW-MOL-SP08

  • Dental delivery system instrument unit, electric

Sealing Cap (Size 6) - 00858395006042

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

  • 00858395006042 ()
  • 00858395006110 ()
GW-MOL-SP06

  • Dental delivery system instrument unit, electric

Sealing Cap (Size 5) - 00858395006035

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

  • 00858395006035 ()
  • 00858395006103 ()
GW-MOL-SP05

  • Dental delivery system instrument unit, electric

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

A-dec - 10194665007300

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

  • 10194665007300 ()
343pro

  • Dental delivery system instrument unit, electric

Advanced Dental/ Endodontics Systems - Umbilical Cart - 00850309007763

Advanced Dental/ Endodontics Systems - Umbilical Cart
ASI MEDICAL, INC.
90-2143DS
In Commercial Distribution

  • 00850309007763 ()


  • Dental delivery system instrument unit, electric

Advanced Dental/ Endodontics Systems - Umbilical Cart - 00850309007497

Advanced Endodontic System - Classic Series Door
ASI MEDICAL, INC.
90-2143ES
In Commercial Distribution

  • 00850309007497 ()


  • Dental delivery system instrument unit, electric

Standard Triton Self-Contained Delivery Systems - 00850309007480

Triton Traveler
ASI MEDICAL, INC.
90-2625
In Commercial Distribution

  • 00850309007480 ()


  • Dental delivery system instrument unit, electric

Extended Worktop - Umbilical Carts - 00850309007466

No Description
ASI MEDICAL, INC.
90-2044
In Commercial Distribution

  • 00850309007466 ()
90-2044

  • Dental delivery system instrument unit, electric

Extended Worktop - Umbilical Carts - 00850309007442

No Description
ASI MEDICAL, INC.
90-2044S
In Commercial Distribution

  • 00850309007442 ()
90-2044S

  • Dental delivery system instrument unit, electric

Extended Worktop - Self-Contained Carts - 00850309007428

No Description
ASI MEDICAL, INC.
90-2006S
In Commercial Distribution

  • 00850309007428 ()
90-2006S

  • Dental delivery system instrument unit, electric

Trident Dental System - Extended Worktop - 00850309007381

Trident Dental System
ASI MEDICAL, INC.
90-2126
In Commercial Distribution

  • 00850309007381 ()
90-2126

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007367

Advanced Endodontic System
ASI MEDICAL, INC.
90-2403E
In Commercial Distribution

  • 00850309007367 ()
90-2403E

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007343

Advanced Endodontic System
ASI MEDICAL, INC.
90-2401E
In Commercial Distribution

  • 00850309007343 ()
90-2401E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007336

Advanced Dental System
ASI MEDICAL, INC.
90-2401D
In Commercial Distribution

  • 00850309007336 ()
90-2401D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007305

Advanced Endodontic System
ASI MEDICAL, INC.
90-2134E/C
In Commercial Distribution

  • 00850309007305 ()
90-2134E/C

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007299

Advanced Dental System
ASI MEDICAL, INC.
90-2134D/C
In Commercial Distribution

  • 00850309007299 ()
90-2134D/C

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007282

Advanced Endodontic System
ASI MEDICAL, INC.
90-2134E
In Commercial Distribution

  • 00850309007282 ()
90-2134E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007275

Advanced Dental System
ASI MEDICAL, INC.
90-2134D
In Commercial Distribution

  • 00850309007275 ()
90-2134D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007268

Advanced Endodontic System
ASI MEDICAL, INC.
90-2133E
In Commercial Distribution

  • 00850309007268 ()
90-2133E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007251

Advanced Dental System
ASI MEDICAL, INC.
90-2133D
In Commercial Distribution

  • 00850309007251 ()
90-2133D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007244

Advanced Endodontic System
ASI MEDICAL, INC.
90-2143E
In Commercial Distribution

  • 00850309007244 ()
90-2143E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007237

Advanced Dental System
ASI MEDICAL, INC.
90-2143D
In Commercial Distribution

  • 00850309007237 ()
90-2143D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007220

Advanced Endodontic System
ASI MEDICAL, INC.
90-2140E
In Commercial Distribution

  • 00850309007220 ()
90-2140E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007213

Advanced Dental System
ASI MEDICAL, INC.
90-2140D
In Commercial Distribution

  • 00850309007213 ()
90-2140D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007206

Advanced Endodontic System
ASI MEDICAL, INC.
90-2255E
In Commercial Distribution

  • 00850309007206 ()
90-2255E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007190

Advanced Dental System
ASI MEDICAL, INC.
90-2255D
In Commercial Distribution

  • 00850309007190 ()
90-2255D

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007176

Advanced Dental System
ASI MEDICAL, INC.
90-2125D
In Commercial Distribution

  • 00850309007176 ()
90-2125D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007169

Advanced Endodontic System
ASI MEDICAL, INC.
90-2115E
In Commercial Distribution

  • 00850309007169 ()
90-2115E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007152

Advanced Dental System
ASI MEDICAL, INC.
90-2115D
In Commercial Distribution

  • 00850309007152 ()
90-2115D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007145

Advanced Endodontic System
ASI MEDICAL, INC.
90-2110E
In Commercial Distribution

  • 00850309007145 ()
90-2110E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007138

Advanced Dental System
ASI MEDICAL, INC.
90-2110D
In Commercial Distribution

  • 00850309007138 ()
90-2110D

  • Dental delivery system instrument unit, electric

Triton - 00850309007121

Triton Dental System
ASI MEDICAL, INC.
90-2025M
In Commercial Distribution

  • 00850309007121 ()
90-2025M

  • Dental delivery system instrument unit, electric
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