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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 Class Implantable

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KALORE™ - D0470035741

KALORE™ Syringes (2 mL/4 g) AO4
Gc America Inc.
003574
In Commercial Distribution

  • D0470035741 ()

  • Total Volume: 2 Milliliter
003574

  • Light-cured dental restorative composite resin

KALORE™ - D0470035731

KALORE™ Syringes (2 mL/4 g) AO3
Gc America Inc.
003573
In Commercial Distribution

  • D0470035731 ()

  • Total Volume: 2 Milliliter
003573

  • Light-cured dental restorative composite resin

KALORE™ - D0470035721

KALORE™ Syringes (2 mL/4 g)AO2
Gc America Inc.
003572
In Commercial Distribution

  • D0470035721 ()

  • Total Volume: 2 Milliliter
003572

  • Light-cured dental restorative composite resin

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

Miracle Mix® - D0470001231

Miracle Mix® 17 g alloy powder btl.
Gc America Inc.
000123
In Commercial Distribution

  • D0470001231 ()

  • Weight: 17 Gram
000123

  • Glass ionomer dental cement

GC Initial™ - J0228758401

GC Initial™ LiSi, Enamel E-60, 20 g
Gc America Inc.
875840
In Commercial Distribution

  • J0228758401 ()

  • Weight: 20 Gram
875840

  • Dental appliance fabrication material, ceramic

GC Initial™ - J0228758391

GC Initial™ LiSi, Enamel E-59, 20 g
Gc America Inc.
875839
In Commercial Distribution

  • J0228758391 ()

  • Weight: 20 Gram
875839

  • Dental appliance fabrication material, ceramic

GC Initial™ - J0228758381

GC Initial™ LiSi, Enamel E-58, 20 g
Gc America Inc.
875838
In Commercial Distribution

  • J0228758381 ()

  • Weight: 20 Gram
875838

  • Dental appliance fabrication material, ceramic

GC Initial™ - J0228758371

GC Initial™ LiSi, Enamel E-57, 20 g
Gc America Inc.
875837
In Commercial Distribution

  • J0228758371 ()

  • Weight: 20 Gram
875837

  • Dental appliance fabrication material, ceramic

GC Initial™ - 15400556706630

GC Initial™ LiSi, Enamel E-60, 20 g
Gc America Inc.
875840
In Commercial Distribution

  • 15400556706630 ()
875840

  • Dental appliance fabrication material, ceramic
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