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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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Lucitone® - D0019059400

No Description
Dentsply International Inc.
Clear Pour Acrylic
Not in Commercial Distribution

  • D0019059501 ()
  • D0019059400 ()

  • Weight: 1000 Gram
905940

  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059370

Pink Intensive
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059471 ()
  • D0019059370 ()

  • Weight: 1000 Gram


  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059360

Pink
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059461 ()
  • D0019059360 ()

  • Weight: 1000 Gram


  • Dental appliance fabrication material, resin

TruTone® - D001892590

No Description
Dentsply International Inc.
Liquid
Not in Commercial Distribution

  • D001892601 ()
  • D001892590 ()

  • Total Volume: 950 Milliliter
89259

  • Dental appliance fabrication material, resin

Dycal® Dentin Radiopaque Calcium Hydroxide Composition - D0026238021

Dycal® Dentin Radiopaque Calcium Hydroxide Composition, Standard Package
DENTSPLY INTERNATIONAL INC.
623802
In Commercial Distribution

  • D00262380262 ()
  • D0026238021 ()

  • Weight: 11 Gram
  • Weight: 13 Gram
  • 1 Base (13g), 1 Catalyst (11g), 1 Mixing Pad
623802

  • Dental composite resin

Dycal® Ivory Radiopaque Calcium Hydroxide Composition - D0026238011

Dycal® Ivory Radiopaque Calcium Hydroxide Composition, Standard Package
DENTSPLY INTERNATIONAL INC.
623801
In Commercial Distribution

  • D00262380162 ()
  • D0026238011 ()

  • 1 Base (13g), 1 Catalyst (11g), 1 Mixing Pad
  • Weight: 11 Gram
  • Weight: 13 Gram
623801

  • Dental composite resin

Algin-X™ Ultra DECA™ - D00261E8101

Algin-X™ Ultra Alginate Alternative Impression Material, Fast Set, 2 (380ml) DECA™ Cartridge Standard Pack
DENTSPLY INTERNATIONAL INC.
61E810
In Commercial Distribution

  • D00261E81082 ()
  • D00261E8101 ()
  • D00261E8100 ()

  • 2 Cartridges (380ml each), 20 Dynamic Mixing Tips, 1 Bayonet Locking Ring
  • Total Volume: 380 Milliliter
61E810

  • Silicone dental impression material

Algin-X™ Ultra Alginate Alternative - D00261E8001

Algin-X™ Ultra Alginate Alternative Impression Material, Fast Set, 4 (50ml) Cartridge Refill
DENTSPLY INTERNATIONAL INC.
61E800
In Commercial Distribution

  • D00261E80082 ()
  • D00261E8001 ()
  • D00261E8000 ()

  • Total Volume: 50 Milliliter
  • 4 Algin-X™ Ultra Cartridges (50mL each) and 6 Mixing Tips
61E800

  • Silicone dental impression material

iNterra™ iNoffice Nightguard - D00261D0401

iNterra™ iNoffice Nightguard Refill Package, Large Arch, 6
DENTSPLY INTERNATIONAL INC.
61D040
Not in Commercial Distribution

  • D00261D04062 ()
  • D00261D0401 ()
  • D00261D0400 ()

  • 6 iNterra™ Nightguard Arches, Large Arch
61D040

  • Custom-made mouthguard

iNterra™ iNoffice Nightguard - D00261D0301

iNterra™ iNoffice Nightguard Refill Package, Medium Arch, 6
DENTSPLY INTERNATIONAL INC.
61D030
Not in Commercial Distribution

  • D00261D03062 ()
  • D00261D0301 ()
  • D00261D0300 ()

  • 6 iNterra™ Nightguard Arches, Medium Arch
61D030

  • Custom-made mouthguard

Calm-it™ Desensitizer - D00261A0041

Calm-It™ Desensitizer Unit Dose Refill
DENTSPLY INTERNATIONAL INC.
61A004
Not in Commercial Distribution

  • D00261A00432 ()
  • D00261A0041 ()
  • D00261A0040 ()

  • 40 Unit Doses and 1 Unit Dose Holder
61A004

  • Dental cavity varnish

Regisil® PB™ Vinyl Polysiloxane Plaster Bite Registration Paste - D0026195101

Regisil® PB™ VPS Bite Reg Material (Pink), Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
619510
In Commercial Distribution

  • D00261951082 ()
  • D0026195101 ()
  • D0026195100 ()

  • Total Volume: 50 Milliliter
  • 4 Cartridges (50mL each), 12 Mixing Tips
619510

  • Silicone dental impression material

Regisil® 2X™ Vinyl Polysiloxane Bite Registration Paste - D0026195001

Regisil® 2X™ VPS Bite Reg Material (Purple), Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
619500
In Commercial Distribution

  • D00261950082 ()
  • D0026195001 ()
  • D0026195000 ()

  • 4 Cartridges (50mL each), 12 Mixing Tips
  • Total Volume: 50 Milliliter
619500

  • Silicone dental impression material

Regisil® Rigid Super Fast Set Cartridge System - D0026194251

Regisil® Rigid Super Fast Set VPS Bite Reg Material (Purple), Cartridge System Refill Package
DENTSPLY INTERNATIONAL INC.
619425
In Commercial Distribution

  • D00261942582 ()
  • D0026194251 ()
  • D0026194250 ()

  • Total Volume: 50 Milliliter
  • 4 Cartridges (50mL each), 12 Mixing Tips
619425

  • Silicone dental impression material

Regisil® Vinyl Polysiloxane Bite Impression Material - D0026191300

Regisil® VPS Bite Reg Material (Purple), Standard Package
DENTSPLY INTERNATIONAL INC.
619130
Not in Commercial Distribution

  • D002619130102 ()
  • D0026191300 ()

  • Total Volume: 90 Milliliter
  • 1 Tube Base (90mL), 1 tube Catalyst (90mL)
619130

  • Silicone dental impression material

IRM® CAPS™ Intermediate Restorative Material - D0026102001

IRM® Caps™ Encapsulated ZOE Intermediate Restorative Material Package
DENTSPLY INTERNATIONAL INC.
610200
In Commercial Distribution

  • D00261020062 ()
  • D0026102001 ()

  • Weight: 0.352 Gram
  • 50 Caps (0.352g each cap)
610200

  • Zinc oxide eugenol dental cement

IRM® Intermediate Restorative Material - D0026100071

IRM® Intermediate Restorative Material, Ivory, Standard Package
DENTSPLY INTERNATIONAL INC.
610007
In Commercial Distribution

  • D00261000762 ()
  • D0026100071 ()

  • Standard Package (Ivory): 1 Powder (38g), 1 Liquid (14mL)
  • Weight: 38 Gram
  • Total Volume: 14 Milliliter
610007

  • Zinc oxide eugenol dental cement

IRM® Intermediate Restorative Material - D0026100041

IRM® Intermediate Restorative Material - Liquid Refill
DENTSPLY INTERNATIONAL INC.
610004
In Commercial Distribution

  • D00261000462 ()
  • D0026100041 ()

  • Total Volume: 14 Milliliter
  • 1 Bottle (14 mL) IRM® Liquid Refill
610004

  • Zinc oxide eugenol dental cement

IRM® Intermediate Restorative Material - D0026100031

IRM® Intermediate Restorative Material - Powder Refill
DENTSPLY INTERNATIONAL INC.
610003
In Commercial Distribution

  • D00261000362 ()
  • D0026100031 ()

  • Weight: 38 Gram
  • Ivory Powder Refill
610003

  • Zinc oxide eugenol dental cement

Enhance® PoGo® Polishing System - D0026620221

PoGo® One Step Diamond Micro-Polisher - Polishing Point Refill Package (40)
DENTSPLY INTERNATIONAL INC.
662022
In Commercial Distribution

  • D0026620222 ()
  • D0026620221 ()
  • D0026620220 ()

  • 30 Polishing Points
662022

  • Dental abrasive disk, reusable

Enhance® PoGo® Polishing System - D0026620101

PoGo One Step Diamond Micro-Polisher, DISC Refill Package (40)
DENTSPLY INTERNATIONAL INC.
662010
In Commercial Distribution

  • D0026620101 ()
  • D0026620100 ()
  • D0026620102 ()

  • 30 Polishing Discs
662010

  • Dental abrasive disk, reusable

Unison® Spherical Alloy - D00265726131

Unison® Spherical Alloy Self-Activating Capsules, 3 Spill, 500 (800mg) Beige/White caps
DENTSPLY INTERNATIONAL INC.
657-2613
Not in Commercial Distribution

  • D00265726132 ()
  • D00265726131 ()
  • D00265726130 ()

  • 10 Jars of 50 Beige/White Capsules per box (800mg alloy each capsule) No.3 Spill
657-2613

  • Dental amalgam alloy

Unison® Spherical Alloy - D00265726121

Unison® Spherical Alloy Self-Activating Capsules, 2 Spill, 500 (600mg) Orange/White caps
DENTSPLY INTERNATIONAL INC.
657-2612
Not in Commercial Distribution

  • D00265726122 ()
  • D00265726121 ()
  • D00265726120 ()

  • 10 Jars of 50 Orange/White Capsules per box (600mg alloy each capsule) No.2 Spill
657-2612

  • Dental amalgam alloy

Unison® Spherical Alloy - D00265726111

Unison® Spherical Alloy Self-Activating Capsules, 1 Spill, 500 (400mg) Brown/White caps
DENTSPLY INTERNATIONAL INC.
657-2611
Not in Commercial Distribution

  • D00265726112 ()
  • D00265726111 ()
  • D00265726110 ()

  • 10 Jars of 50 Brown/White Capsules per box (400mg alloy each capsule) No.1 Spill
657-2611

  • Dental amalgam alloy

Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules - D0026562931

Dispersed Phase Alloy, Regular Set, 3 Spill, 2000 (800mg) Yellow/White caps
DENTSPLY INTERNATIONAL INC.
656293
Not in Commercial Distribution

  • D0026562932 ()
  • D0026562931 ()
  • D0026562930 ()

  • Regular Set, 3 Spill, 4 cartons of 500 (800mg) Yellow/White caps
  • Weight: 800 Milligram
656293

  • Dental amalgam alloy

Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules - D0026562921

Dispersed Phase Alloy, Regular Set, 2 Spill, 2000 (600mg) Blue/White caps
DENTSPLY INTERNATIONAL INC.
656292
Not in Commercial Distribution

  • D0026562922 ()
  • D0026562921 ()
  • D0026562920 ()

  • Weight: 600 Milligram
  • Regular Set, 2 Spill, 4 cartons of 500 (600mg) Blue/White caps
656292

  • Dental amalgam alloy

Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules - D0026562911

Dispersalloy Dispersed Phase Alloy, Regular Set, 1 Spill, 2000 (400mg) Green/White caps
DENTSPLY INTERNATIONAL INC.
656291
Not in Commercial Distribution

  • D0026562912 ()
  • D0026562911 ()
  • D0026562910 ()

  • Weight: 400 Milligram
  • Regular Set, 1 Spill, 4 cartons of 500 (400mg) Green/White caps
656291

  • Dental amalgam alloy

Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules - D00265628931

Dispersed Phase Alloy, Regular Set, 3 Spill, 500 (800mg) Yellow caps
DENTSPLY INTERNATIONAL INC.
656-2893
Not in Commercial Distribution

  • D00265628932 ()
  • D00265628931 ()
  • D00265628930 ()

  • Weight: 800 Milligram
  • Regular Set, 3 Spill, 10 cartons of 50 (800mg) Yellow caps
656-2893

  • Dental amalgam alloy

Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules - D00265628921

Dispersed Phase Alloy, Regular Set, 2 Spill, 500 (600mg) Blue/White caps
DENTSPLY INTERNATIONAL INC.
656-2892
Not in Commercial Distribution

  • D00265628922 ()
  • D00265628921 ()
  • D00265628920 ()

  • Regular Set, 2 Spill, 10 cartons of 50 (600mg) Blue/White caps
  • Weight: 600 Milligram
656-2892

  • Dental amalgam alloy

Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules - D00265628911

Dispersed Phase Alloy, Regular Set, 1 Spill, 500 (400mg) Green caps
DENTSPLY INTERNATIONAL INC.
656-2891
Not in Commercial Distribution

  • D00265628912 ()
  • D00265628911 ()
  • D00265628910 ()

  • Regular Set, 1 Spill, 10 cartons of 50 (400mg) Green caps
  • Weight: 400 Milligram
656-2891

  • Dental amalgam alloy
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