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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 Initial™ - D0470128291

Initial LiSi Press Ingot MT-B3 (3gx5)
Gc America Inc.
012829
In Commercial Distribution

  • D0470128294 ()
  • D0470128291 ()
012829

  • Dental appliance fabrication material, ceramic

GC Initial™ - D0470128281

Initial LiSi Press Ingot MT-A4 (3gx5)
Gc America Inc.
012828
In Commercial Distribution

  • D0470128284 ()
  • D0470128281 ()
012828

  • Dental appliance fabrication material, ceramic

GC Reline ™ - D0470006001

GC Reline ™ Extra Soft Intro Package 1 (48mL) cartridge of extra soft, 6 type 2L mixing tips, 13mL bottle of Primer R, 1 silicone point, 9mL bottles of Reline Modifier Parts A 7 B, mixing pad, pellet sponges, spatula, scoop and brush
Gc America Inc.
000600
Not in Commercial Distribution

  • D0470006002 ()
  • D0470006001 ()
000600

  • Denture reliner, elastic, short-term

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

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 ORTHO™ - D0470002091

GC Fuji ORTHO™ 40 g powder btl
Gc America Inc.
000209
In Commercial Distribution

  • D0470002092 ()
  • D0470002091 ()

  • Weight: 40 Gram
000209

  • Glass ionomer dental cement

GC Fuji BOND™ LC - D0470002071

GC Fuji BOND™ LC Standard set (5 g powder, 7 mL liquid & 5.7 mL GC Cavity Conditioner )
Gc America Inc.
000207
In Commercial Distribution

  • D0470002072 ()
  • D0470002071 ()
000207

  • Dentine adhesive

GC Fuji II LC® - D0470002061

GC Fuji II LC® 6.8 mL liquid btl
Gc America Inc.
000206
In Commercial Distribution

  • D0470002062 ()
  • D0470002061 ()

  • Total Volume: 6.8 Milliliter
000206

  • Glass ionomer dental cement

GC Fuji II LC® - D0470002041

GC Fuji II LC® C4, 15 g powder btl
Gc America Inc.
000204
In Commercial Distribution

  • D0470002042 ()
  • D0470002041 ()

  • Weight: 15 Gram
000204

  • Glass ionomer dental cement

GC Fuji II LC® - D0470002011

GC Fuji II LC® B3, 15 g powder btl
Gc America Inc.
000201
In Commercial Distribution

  • D0470002012 ()
  • D0470002011 ()

  • Weight: 15 Gram
000201

  • Glass ionomer dental cement

GC Fuji II LC® - D0470002001

GC Fuji II LC® B2, 15 g powder btl
Gc America Inc.
000200
In Commercial Distribution

  • D0470002002 ()
  • D0470002001 ()

  • Weight: 15 Gram
000200

  • 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

GC Fuji II LC® - D0470001821

GC Fuji II LC® Core 35 g powder btl.
Gc America Inc.
000182
In Commercial Distribution

  • D0470001822 ()
  • D0470001821 ()

  • Weight: 35 Gram
000182

  • Glass ionomer dental cement

GC Fuji BOND™ - D0470001801

GC Fuji BOND™ LC 7 mL liquid btl.
Gc America Inc.
000180
In Commercial Distribution

  • D0470001802 ()
  • D0470001801 ()

  • Total Volume: 7 Milliliter
000180

  • Dentine adhesive

GC Fuji COAT™ - D0470001761

GC Fuji COAT™ LC 5.2 mL liquid
Gc America Inc.
000176
In Commercial Distribution

  • D0470001762 ()
  • D0470001761 ()

  • Total Volume: 5.2 Milliliter
000176

  • Dental restorative material varnish

GC Fuji IX GP® - D0470001641

GC Fuji IX GP® 6.4 mL liquid btl.
Gc America Inc.
000164
In Commercial Distribution

  • D0470001642 ()
  • D0470001641 ()

  • Total Volume: 6.4 Milliliter
000164

  • Glass ionomer dental cement

GC Fuji IX GP® - D0470001581

GC Fuji IX GP® A2, 15 g powder
Gc America Inc.
000158
In Commercial Distribution

  • D0470001582 ()
  • D0470001581 ()

  • Weight: 15 Gram
000158

  • Glass ionomer dental cement

GC Fuji IX GP® - D0470001521

GC Fuji IX GP® Intro Package, 1-1 Pack,1 btl. Powder, Shade A2 (15g) 1 btl liquid (6.4ml), mixing pad
Gc America Inc.
000152
In Commercial Distribution

  • D0470001522 ()
  • D0470001521 ()
000152

  • Glass ionomer dental cement

GC Fuji LINING™ - D0470001281

GC Fuji LINING™ LC 6.8 mL liquid btl.
Gc America Inc.
000128
In Commercial Distribution

  • D0470001282 ()
  • D0470001281 ()

  • Total Volume: 6.8 Milliliter
000128

  • Dental cavity liner

Miracle Mix® - D0470001221

Miracle Mix® 8mL liquid btl.
Gc America Inc.
000122
In Commercial Distribution

  • D0470001222 ()
  • D0470001221 ()

  • Weight: 10 Gram
000122

  • Glass ionomer dental cement
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