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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™ - D0470035761

KALORE™ Syringes (2 mL/4 g) OXBW
Gc America Inc.
003576
In Commercial Distribution

  • D0470035761 ()

  • Total Volume: 2 Milliliter
003576

  • Light-cured dental restorative composite resin

KALORE™ - D0470035751

KALORE™ Syringes (2 mL/4 g) OBW
Gc America Inc.
003575
In Commercial Distribution

  • D0470035751 ()

  • Total Volume: 2 Milliliter
003575

  • Light-cured dental restorative composite resin

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

KALORE™ - 14548161293150

KALORE™ Syringes (2 mL/4 g) A4
Gc America Inc.
003581
In Commercial Distribution

  • 14548161293150 ()

  • Total Volume: 2 Milliliter
003581

  • Dental composite resin

KALORE™ - 14548161293143

KALORE™ Syringes (2 mL/4 g) A3.5
Gc America Inc.
003580
In Commercial Distribution

  • 14548161293143 ()

  • Total Volume: 2 Milliliter
003580

  • Dental composite resin

KALORE™ - 14548161293136

KALORE™ Syringes (2 mL/4 g) A3
Gc America Inc.
003579
In Commercial Distribution

  • 14548161293136 ()

  • Total Volume: 2 Milliliter
003579

  • Dental composite resin
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