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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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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
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
iNterra™ iNoffice Nightguard Starter Kit
DENTSPLY INTERNATIONAL INC.
61D010
Not in Commercial Distribution

  • D00261D01062 ()
  • D00261D0101 ()

  • Total Volume: 50 Milliliter
  • 1 Small Arch, 2 Medium Arches, 1 Large Arch, 1 Cartridge Regisil® Rigid Super Fast Set Material (50mL), 6 Mixing Tips
61D010

  • Custom-made mouthguard
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
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, 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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