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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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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® 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™ 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, 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 - 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 - Powder Refill
DENTSPLY INTERNATIONAL INC.
610003
In Commercial Distribution

  • D00261000362 ()
  • D0026100031 ()

  • Weight: 38 Gram
  • Ivory Powder Refill
610003

  • Zinc oxide eugenol dental cement
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
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 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 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
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