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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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GC Fuji II® Yellow Brown, 15 g powder
Gc America Inc.
000096
In Commercial Distribution

  • D0470000962 ()
  • D0470000961 ()

  • Weight: 15 Gram
000096

  • Glass ionomer dental cement
GC Fuji II® Pale Yellow, 15 g powder
Gc America Inc.
000095
In Commercial Distribution

  • D0470000952 ()
  • D0470000951 ()

  • Weight: 15 Gram
000095

  • Glass ionomer dental cement
ISO FUNCTIONAL STICKS Box of 120 g (15 x sticks, 8 g each)
Gc America Inc.
000043
In Commercial Distribution

  • D0470000432 ()
  • D0470000431 ()
  • D0470000430 ()

  • Weight: 8 Gram
000043

  • Composite dental impression material
GC Fuji ORTHO™ 8g (6.8 mL) liquid
Gc America Inc.
000030
In Commercial Distribution

  • D0470000302 ()
  • D0470000301 ()

  • Total Volume: 6.8 Milliliter
000030

  • Glass ionomer dental cement
GC Fuji ORTHO™ 40 g powder
Gc America Inc.
000029
In Commercial Distribution

  • D0470000292 ()
  • D0470000291 ()

  • Weight: 40 Gram
000029

  • Glass ionomer dental cement
GC Fuji VARNISH™ 10 g liquid
Gc America Inc.
000026
In Commercial Distribution

  • D0470000262 ()
  • D0470000261 ()

  • Total Volume: 10 Milliliter
000026

  • Dental restorative material varnish
GC Fuji LINING™ 10 g powder
Gc America Inc.
000022
In Commercial Distribution

  • D0470000222 ()
  • D0470000221 ()

  • Weight: 10 Gram
000022

  • Dental cavity liner
GC Fuji LINING™ Intro Package, 1-1 Pack (1 x 10 g powder, 1 x 6.8 mL liquid & accessories)
Gc America Inc.
000021
In Commercial Distribution

  • D0470000212 ()
  • D0470000211 ()
000021

  • Dental cavity liner
High viscosity flowable composite. Light cured micro hybrid.
RIBBOND, INC
1
In Commercial Distribution

  • D046C1 ()
  • D046CC0 ()
TIPS

  • Dental composite resin
Total Etch Adhesive, 2 (4.5ml) Bottle Refill Package
DENTSPLY INTERNATIONAL INC.
634352
In Commercial Distribution

  • D00263435262 ()
  • D0026343521 ()
  • D0026343520 ()

  • Total Volume: 4.5 Milliliter
  • 2 Bottles Total Etch Adhesive (4.5mL)
634352

  • Dentine adhesive
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