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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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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 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 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 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
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
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