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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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Aquasil® Ultra Monophase Smart Wetting® Impression Material - D0026786821

Aquasil® Ultra+ Medium Regular Set DECA 5:1 (2-pack)
DENTSPLY INTERNATIONAL INC.
678682
In Commercial Distribution

  • D00267868232 ()
  • D0026786821 ()
  • D0026786820 ()

  • Total Volume: 380 Milliliter
  • 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring
678682

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786781

Aquasil® Ultra+ Rigid Fast Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678678
In Commercial Distribution

  • D00267867882 ()
  • D0026786781 ()
  • D0026786780 ()

  • Total Volume: 50 Milliliter
  • 32 (50mL) cartridges, 12 mixing tips
678678

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786761

Aquasil® Ultra+ Heavy Fast Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678676
In Commercial Distribution

  • D00267867682 ()
  • D0026786761 ()
  • D0026786760 ()

  • 32 (50mL) cartridges, 12 mixing tips
  • Total Volume: 50 Milliliter
678676

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786751

Aquasil® Ultra+ Heavy Regular Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678675
Not in Commercial Distribution

  • D00267867582 ()
  • D0026786751 ()
  • D0026786750 ()

  • 32 (50mL) cartridges, 12 mixing tips
  • Total Volume: 50 Milliliter
678675

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786741

Aquasil® Ultra+ Medium Fast Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678674
In Commercial Distribution

  • D00267867482 ()
  • D0026786741 ()
  • D0026786740 ()

  • Total Volume: 50 Milliliter
  • 32 (50mL) cartridges, 12 mixing tips
678674

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786731

Aquasil® Ultra+ Medium Regular Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678673
In Commercial Distribution

  • D00267867382 ()
  • D0026786731 ()
  • D0026786730 ()

  • Total Volume: 50 Milliliter
  • 32 (50mL) cartridges, 12 mixing tips
678673

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786721

Aquasil® Ultra+ LV Fast Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678672
In Commercial Distribution

  • D00267867282 ()
  • D0026786721 ()
  • D0026786720 ()

  • 32 (50mL) cartridges, 12 mixing tips, 12 intraoral tips
  • Total Volume: 50 Milliliter
678672

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786711

Aquasil® Ultra+ LV Regular Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678671
In Commercial Distribution

  • D00267867182 ()
  • D0026786711 ()
  • D0026786710 ()

  • Total Volume: 50 Milliliter
  • 32 (50mL) cartridges, 12 mixing tips, 12 intraoral tips
678671

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786701

Aquasil® Ultra+ XLV Fast Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678670
Not in Commercial Distribution

  • D00267867082 ()
  • D0026786701 ()
  • D0026786700 ()

  • 32 (50mL) cartridges, 12 mixing tips, 12 intraoral tips
  • Total Volume: 50 Milliliter
678670

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786681

Aquasil® Ultra+ XLV Regular Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678668
Not in Commercial Distribution

  • D00267866882 ()
  • D0026786681 ()
  • D0026786680 ()

  • Total Volume: 50 Milliliter
  • 32 (50mL) cartridges, 12 mixing tips, 12 intraoral tips
678668

  • Silicone dental impression material

Aquasil Ultra LV Fast Set Smart Wetting® Impression Material - D0026784501

Aquasil Ultra LV Fast Set with B4® Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
678450
In Commercial Distribution

  • D00267845082 ()
  • D0026784501 ()
  • D0026784500 ()

  • Total Volume: 50 Milliliter
  • Total Volume: 6 Milliliter
  • 4 cartridges LV FS (50ml), 1 bottle B4 (6ml), 24 Mixing Tips, 24 Intra Oral Tips, 50 Flocked Applicator Tips, 1 Dispensing Well
678450

  • Silicone dental impression material

Aquasil Ultra Smart Wetting® Impression Material Cartridge System - D0026784251

Aquasil LV Regular Set Cartridge Refill Package - Teal
DENTSPLY INTERNATIONAL INC.
678425
Not in Commercial Distribution

  • D00267842582 ()
  • D0026784251 ()
  • D0026784250 ()

  • Total Volume: 50 Milliliter
  • 4 (50mL) Cartridges, 12 Mixing Tips
678425

  • Silicone dental impression material

Aquasil Ultra Smart Wetting® Impression Material Cartridge System - D0026784151

Aquasil LV Fast Set Cartridge Refill Package -Teal
DENTSPLY INTERNATIONAL INC.
678415
Not in Commercial Distribution

  • D00267841582 ()
  • D0026784151 ()
  • D0026784150 ()

  • 4 (50mL) Cartridges, 12 Mixing Tips
  • Total Volume: 50 Milliliter
678415

  • Silicone dental impression material

Aquasil Ultra Smart Wetting® Impression Material Cartridge System - D0026783551

Aquasil Rigid Fast Set Cartridge Refill Package - Light Green
DENTSPLY INTERNATIONAL INC.
678355
Not in Commercial Distribution

  • D00267835582 ()
  • D0026783551 ()
  • D0026783550 ()

  • 4 (50mL) Cartridges, 12 Mixing Tips
  • Total Volume: 50 Milliliter
678355

  • Silicone dental impression material

Aquasil Ultra Smart Wetting® Impression Material Cartridge System - D0026783501

Aquasil Rigid Regular Set Cartridge Refill Package - Light Green
DENTSPLY INTERNATIONAL INC.
678350
Not in Commercial Distribution

  • D00267835082 ()
  • D0026783501 ()
  • D0026783500 ()

  • 4 (50mL) Cartridges, 12 Mixing Tips
  • Total Volume: 50 Milliliter
678350

  • Silicone dental impression material

Aquasil LV Smart Wetting® Impression Material - D0026783001

Aquasil Ultra LV Standard Tube Refill
DENTSPLY INTERNATIONAL INC.
678300
Not in Commercial Distribution

  • D002678300102 ()
  • D0026783001 ()

  • Total Volume: 90 Milliliter
  • 1 Tube Base (90mL), 1 Tube Catalyst (90mL)
678300

  • Silicone dental impression material

Aquasil Ultra Smart Wetting® Impression Material Cartridge System - D0026782501

Aquasil Monophase Regular Set Cartridge Refill Package - Purple
DENTSPLY INTERNATIONAL INC.
678250
Not in Commercial Distribution

  • D00267825082 ()
  • D0026782501 ()
  • D0026782500 ()

  • Total Volume: 50 Milliliter
  • 4 (50mL) Cartridges, 12 Mixing Tips
678250

  • Silicone dental impression material

Aquasil Ultra Smart Wetting® Impression Material with B4™ Cartridge System - D0026781601

Aquasil Ultra XLV Fast Set, with B4™ Pre-Impression Surface Optimizer Cartridge Refill Package (Orange)
DENTSPLY INTERNATIONAL INC.
678160
Not in Commercial Distribution

  • D00267816082 ()
  • D0026781601 ()
  • D0026781600 ()

  • Total Volume: 6 Milliliter
  • Total Volume: 50 Milliliter
  • 4 (50mL) Cartridges, 1 Bottle B4™, 12 Mixing Tips, 50 Flocked Applicator Tips, 1 Dispensing Well
678160

  • Silicone dental impression material

Aquasil Ultra Smart Wetting® Impression Material with B4™ Cartridge System - D0026781501

Aquasil Ultra LV Fast Set (Teal) Cartridge Refill Package with B4™ Optimizer
DENTSPLY INTERNATIONAL INC.
678150
Not in Commercial Distribution

  • D00267815082 ()
  • D0026781501 ()
  • D0026781500 ()

  • Total Volume: 50 Milliliter
  • Total Volume: 6 Milliliter
  • 4 (50mL) Cartridges, 1 Bottle Optimizer, 12 Mixing Tips, 50 Flocked Applicator Tips, 1 Dispensing Well
678150

  • Silicone dental impression material

Aquasil Ultra Smart Wetting® Impression Material with B4™ Cartridge System - D0026781401

Aquasil Ultra XLV Regular Set, with B4™ Pre-Impression Surface Optimizer Cartridge Refill Package (Orange)
DENTSPLY INTERNATIONAL INC.
678140
Not in Commercial Distribution

  • D00267814082 ()
  • D0026781401 ()
  • D0026781400 ()

  • 4 (50mL) Cartridges, 1 Bottle B4™, 12 Mixing Tips, 50 Flocked Applicator Tips, 1 Dispensing Well
  • Total Volume: 50 Milliliter
  • Total Volume: 6 Milliliter
678140

  • Silicone dental impression material

Aquasil Ultra Smart Wetting® Impression Material with B4™ Cartridge System - D0026781301

Aquasil Ultra LV Regular Set (Teal) Cartridge Refill Package with B4™ Optimizer
DENTSPLY INTERNATIONAL INC.
678130
Not in Commercial Distribution

  • D00267813082 ()
  • D0026781301 ()
  • D0026781300 ()

  • 4 (50mL) Cartridges, 1 Bottle B4™ (6mL), 12 Mixing Tips, 50 Flocked Applicator Tips, 1 Dispensing Well
  • Total Volume: 6 Milliliter
  • Total Volume: 50 Milliliter
678130

  • Silicone dental impression material

Aquasil Monophase Smart Wetting® Impression Material - D0026781001

Aquasil Monophase Tube Refill
DENTSPLY INTERNATIONAL INC.
678100
Not in Commercial Distribution

  • D002678100102 ()
  • D0026781001 ()

  • Total Volume: 90 Milliliter
  • 1 Tube Base (90mL), 1 Tube Catalyst (90mL)
678100

  • Silicone dental impression material

Aquasil Ultimate DECA™ Tissue Managing Tray Impression System - D002678059I1

Aquasil Ultimate Tissue Managing Impression System, Tray (Light Green), 2 (380ml) DECA™ Cartridge Standard Pack
DENTSPLY INTERNATIONAL INC.
678059I
In Commercial Distribution

  • D002678059I32 ()
  • D002678059I1 ()
  • D002678059I0 ()

  • Total Volume: 380 Milliliter
  • 2 DECA cartridges, 20 Mixing Tips, 1 Bayonet Ring
678059I

  • Silicone dental impression material

Aquasil Ultimate Tissue Managing Tray Impression System DECA™ - D0026780591

Aquasil Ultra Cordless Tissue Managing Impression System Tray (Light Green) 2 (380ml) DECA™ Cartridge Standard Pack
DENTSPLY INTERNATIONAL INC.
678059
In Commercial Distribution

  • D00267805932 ()
  • D0026780591 ()
  • D0026780590 ()

  • 2 DECA™ cartridges, 20 Mixing Tips, 1 Bayonet Ring
  • Total Volume: 380 Milliliter
678059

  • Silicone dental impression material

Aquasil Ultimate Tissue Managing Tray Impression System - D002678056I1

Aquasil Ultimate Tissue Managing Tray Impression System (Light Green), 4 (50ml) Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678056I
Not in Commercial Distribution

  • D002678056I2 ()
  • D002678056I1 ()
  • D002678056I0 ()

  • 4 (50ml) Cartridges Refill, 12 Mixing Tips (Green)
  • Total Volume: 50 Milliliter
678056I

  • Silicone dental impression material

Aquasil Ultimate Tissue Managing Tray Impression System - D0026780561

Aquasil Ultimate Tissue Managing Tray Impression System Cartridge Refill (Light Green)
DENTSPLY INTERNATIONAL INC.
678056
In Commercial Distribution

  • D00267805682 ()
  • D0026780561 ()
  • D0026780560 ()

  • Total Volume: 50 Milliliter
  • 4 (50ml) Cartridges Refill, 12 Mixing Tips (Green)
678056

  • Silicone dental impression material

Xeno® IV One Component Light Cured Self-Etching Dental Adhesive - D0026680041

Xeno® IV One Component Self-Etching Dental Adhesive Refill Package, 2 (4.5ml) Bottles
DENTSPLY INTERNATIONAL INC.
668004
In Commercial Distribution

  • D00266800462 ()
  • D0026680041 ()
  • D0026680040 ()

  • 2 Bottles Xeno® IV (4.5mL)
  • Total Volume: 4.5 Milliliter
668004

  • Dentine adhesive

Prime&Bond® NT™ Nano-Technology Light Cured Dental Adhesive - D0026343521

Total Etch Adhesive, 2 (4.5ml) Bottle Refill Package
DENTSPLY INTERNATIONAL INC.
634352
In Commercial Distribution

  • D00263435262 ()
  • D0026343521 ()
  • D0026343520 ()

  • Total Volume: 4.5 Milliliter
  • 2 Bottles Total Etch Adhesive (4.5mL)
634352

  • Dentine adhesive

Prime&Bond® NT™ Nano-Technology Light Cured Dental Adhesive - D0026343511

Prime&Bond® NT™ Total Etch Adhesive Bottle Economy Package
DENTSPLY INTERNATIONAL INC.
634351
In Commercial Distribution

  • D00263435162 ()
  • D0026343511 ()

  • Total Volume: 3 Milliliter
  • 3 Bottles Adhesive, 120 Disposable Brush Tips, 1 Brush Handle, 2 Syringes Tooth Conditioner Gel, 75 Applicator Tips (Needles), 1 Dispensing Well
  • Total Volume: 4.5 Milliliter
634351

  • Dentine adhesive

Prisma® Gloss™ Composite Polishing Paste System - D0026314500

Prisma® Gloss™ Composite Polishing Paste System Syringe Refill - Extra Fine
DENTSPLY INTERNATIONAL INC.
631450
In Commercial Distribution

  • D00263145042 ()
  • D0026314500 ()

  • 1 Syringe Polishing Paste Extra Fine (4g)
  • Weight: 4 Gram
631450

  • Dental unfilled resin sealant/coating

Prisma® Gloss™ Composite Polishing Paste System - D0026314000

Prisma® Gloss™ Composite Polishing Paste System Syringe Refill
DENTSPLY INTERNATIONAL INC.
631400
In Commercial Distribution

  • D00263140042 ()
  • D0026314000 ()

  • 1 Syringe Polishing Paste (4g)
  • Weight: 4 Gram
631400

  • Dental unfilled resin sealant/coating

Reprosil® Hydrophilic Vinyl Polysiloxane Impression Material - D0026266001

Reprosil® VPS Impression Material, Light Body (Orange), 4 (50ml) Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
626600
In Commercial Distribution

  • D00262660082 ()
  • D0026266001 ()
  • D0026266000 ()

  • Total Volume: 50 Milliliter
  • 4 Cartridges (50mL each), 12 Mixing Tips
626600

  • Silicone dental impression material

Reprosil® Quixx Putty Vinyl Polysiloxane Impression Material - D0026262301

Reprosil® Quixx Putty VPS Impression Material (Brown), Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
626230
In Commercial Distribution

  • D00262623082 ()
  • D0026262301 ()
  • D0026262300 ()

  • 4 Cartridges (50mL each), 12 Mixing Tips
  • Total Volume: 50 Milliliter
626230

  • Silicone dental impression material

Reprosil® Hydrophilic Vinyl Polysiloxane Impression Material - D0026262201

Reprosil® VPS Impression Material, Heavy Body (Green), 4 (50ml) Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
626220
In Commercial Distribution

  • D00262622082 ()
  • D0026262201 ()
  • D0026262200 ()

  • Total Volume: 50 Milliliter
  • 4 Cartridges (50mL each), 12 Mixing Tips
626220

  • Silicone dental impression material

Reprosil® Hydrophilic Vinyl Polysiloxane Impression Material - D0026262101

Reprosil® VPS Impression Material, Regular Body (Blue), 4 (50ml) Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
626210
In Commercial Distribution

  • D00262621082 ()
  • D0026262101 ()
  • D0026262100 ()

  • Total Volume: 50 Milliliter
  • 4 Cartridges (50mL each), 12 Mixing Tips
626210

  • Silicone dental impression material

Reprosil® Hydrophilic Vinyl Polysiloxane Impression Material - D0026261801

Reprosil® VPS Impression Material, Heavy Body (Green), 180 mL Tube Package
DENTSPLY INTERNATIONAL INC.
626180
Not in Commercial Distribution

  • D002626180102 ()
  • D0026261801 ()

  • 1 Tube Base (90mL), 1 tube Catalyst (90mL)
  • Total Volume: 90 Milliliter
626180

  • Silicone dental impression material

Reprosil® Hydrophilic Vinyl Polysiloxane Impression Material - D0026261751

Reprosil® VPS Impression Material, Regular Body (Blue), 180mL Tube Package
DENTSPLY INTERNATIONAL INC.
626175
In Commercial Distribution

  • D002626175102 ()
  • D0026261751 ()

  • Total Volume: 90 Milliliter
  • 1 Tube Base (90mL), 1 tube Catalyst (90mL)
626175

  • Silicone dental impression material

Reprosil® Hydrophilic Vinyl Polysiloxane Impression Material - D0026261701

Reprosil® VPS Impression Material, Light Body (Orange), 180mL Tube Package
DENTSPLY INTERNATIONAL INC.
626170
In Commercial Distribution

  • D002626170102 ()
  • D0026261701 ()

  • 1 Tube Base (90mL), 1 Tube Catalyst (90mL)
  • Total Volume: 90 Milliliter
626170

  • Silicone dental impression material

Hydrosil® Hydromonophase Vinyl Polysiloxane Impression Material - D0026251301

Hydrosil® Hydromonophase VPS Impression Material 180ml Tube Package
DENTSPLY INTERNATIONAL INC.
625130
Not in Commercial Distribution

  • D002625130102 ()
  • D0026251301 ()

  • Total Volume: 90 Milliliter
  • 1 (90ml) Tube Base and 1 (90ml) Tube Catalyst - Standard
625130

  • Silicone dental impression material

iNterra™ iNoffice Nightguard - D00261D0201

iNterra™ iNoffice Nightguard Refill Package, Small Arch, 6
DENTSPLY INTERNATIONAL INC.
61D020
Not in Commercial Distribution

  • D00261D02062 ()
  • D00261D0201 ()
  • D00261D0200 ()

  • 6 iNterra™ Nightguard Arches, Small Arch
61D020

  • Custom-made mouthguard
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