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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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CERASMART® - D0470083431

CERASMART® (Cerec Size 12), Shade A2, High Translucency, 5 pieces
Gc America Inc.
008343
In Commercial Distribution

  • D0470083432 ()
  • D0470083431 ()
  • D0470083430 ()
008343

  • Dental implant suprastructure, permanent, preformed

GC FujiCEM™ - D0470015731

GC FujiCEM™  GC Paste Pak Dispenser
Gc America Inc.
001573
In Commercial Distribution

  • D0470015732 ()
  • D0470015731 ()
001573

  • Dental material cartridge-plunging applicator, two-component, manual

GC METALPRIMER II - D0470005541

GC METALPRIMER II Kit 5 mL liquid & 1 brush
Gc America Inc.
000554
In Commercial Distribution

  • D0470005542 ()
  • D0470005541 ()

  • Total Volume: 5 Milliliter
000554

  • Dental etching solution

UNIFAST™ - D0470003681

UNIFAST™LC 2 x 14.7 mL liquid btl
Gc America Inc.
000368
In Commercial Distribution

  • D0470003682 ()
  • D0470003681 ()

  • Total Volume: 14.7 Milliliter
000368

  • Temporary dental crown/bridge resin

Miracle Mix® - D0470002391

Miracle Mix® Kit (15 g powder, 8mL liquid, 17 g alloy powder)
Gc America Inc.
000239
In Commercial Distribution

  • D0470002392 ()
  • D0470002391 ()
000239

  • Glass ionomer dental cement

GC Fuji PLUS® - D0470002211

GC Fuji PLUS® Conditioner btl. (6.5 mL)
Gc America Inc.
000221
In Commercial Distribution

  • D0470002212 ()
  • D0470002211 ()

  • Weight: 7 Gram
000221

  • Dental etching solution

GC Fuji ORTHO™ - D0470002101

GC Fuji ORTHO™ (6.8 mL) liquid btl
Gc America Inc.
000210
In Commercial Distribution

  • D0470002102 ()
  • D0470002101 ()

  • Weight: 8 Gram
000210

  • Glass ionomer dental cement

GC Fuji II LC® - D0470001861

GC Fuji II LC® A3, 1-1 Pack (1 x 15 g powder, 1 x 6.8 mL liquid & accessories)
Gc America Inc.
000186
In Commercial Distribution

  • D0470001862 ()
  • D0470001861 ()
000186

  • Glass ionomer dental cement

GC Fuji II LC® - D0470001851

GC Fuji II LC® A2, 1-1 Pack (1 x 15 g powder, 1 x 6.8mL liquid & accessories)
Gc America Inc.
000185
In Commercial Distribution

  • D0470001852 ()
  • D0470001851 ()
000185

  • Glass ionomer dental cement

GC Fuji II LC® - D0470001841

GC Fuji II LC® A1, 1-1 Pack (1 x 15 g powder, 1 x 6.8 mL liquid & accessories)
Gc America Inc.
000184
In Commercial Distribution

  • D0470001842 ()
  • D0470001841 ()
000184

  • Glass ionomer dental cement
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