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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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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™ 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™ 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 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
Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 3 Spill Case (Lime Green)
DENTSPLY INTERNATIONAL INC.
603016
Not in Commercial Distribution

  • D0026030162 ()
  • D0026030161 ()
  • D0026030160 ()

  • Weight: 800 Milligram
  • No. 3 Spill Case (Lime Green) 4 Jars of 250 Capsules (800mg alloy each Capsule)
603016

  • Dental amalgam alloy
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