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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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GC Initial™ - 15400556709662

GC Initial™ IQ/Effect Ingot B1-M, 4 pcs. X 5 g
Gc America Inc.
872523
In Commercial Distribution

  • 15400556709662 ()
872523

  • Dental appliance fabrication material, ceramic

G-aenial™ - 14548161323338

G-aenial™ Universal Flo AE, 1 syringe (2 mL/3.4 g per syringe)
Gc America Inc.
004216
In Commercial Distribution

  • 14548161323338 ()

  • Total Volume: 2 Milliliter
004216

  • Dental composite resin

G-aenial™ - 14548161323291

G-aenial™ Universal Flo AO3, 1 syringe (2 mL/3.4 g per syringe)
Gc America Inc.
004212
In Commercial Distribution

  • 14548161323291 ()

  • Total Volume: 2 Milliliter
004212

  • Dental composite resin

G-aenial™ - 14548161323222

G-aenial™ Universal Flo A3.5, 1 syringe (2 mL/3.4 g per syringe)
Gc America Inc.
004205
In Commercial Distribution

  • 14548161323222 ()

  • Total Volume: 2 Milliliter
004205

  • Dental composite resin

G-aenial™ - D0470042161

G-aenial™ Universal Flo AE, 1 syringe (2 mL/3.4 g per syringe)
Gc America Inc.
004216
In Commercial Distribution

  • D0470042161 ()

  • Total Volume: 2 Milliliter
004216

  • Light-cured dental restorative composite resin

G-aenial™ - D0470042121

G-aenial™ Universal Flo AO3, 1 syringe (2 mL/3.4 g per syringe)
Gc America Inc.
004212
In Commercial Distribution

  • D0470042121 ()

  • Total Volume: 2 Milliliter
004212

  • Light-cured dental restorative composite resin

G-aenial™ - D0470042051

G-aenial™ Universal Flo A3.5, 1 syringe (2 mL/3.4 g per syringe)
Gc America Inc.
004205
In Commercial Distribution

  • D0470042051 ()

  • Total Volume: 2 Milliliter
004205

  • Light-cured dental restorative composite resin

GC Fuji II LC® - 14548161329804

GC Fuji II LC® B4, 15 g powder, 1 btl liquid (6.8mL), accessories
Gc America Inc.
000191
In Commercial Distribution

  • 14548161329804 ()

  • Weight: 15 Gram
000191

  • Glass ionomer dental cement

GRADIA® - 14548161322263

GRADIA® DIRECT X Unitips - 10 tips 0.16 mL/0.30 g - Unitip s X-C2
Gc America Inc.
002599
In Commercial Distribution

  • 04548161322266 ()
  • 14548161322263 ()

  • Total Volume: 0.16 Milliliter
002599

  • Dental composite resin

GRADIA® - D0470025991

GRADIA® DIRECT X Unitips - 10 tips 0.16 mL/0.30 g - Unitip s X-C2
Gc America Inc.
002599
In Commercial Distribution

  • D0470025991 ()
  • D0470025990 ()

  • Total Volume: 0.16 Milliliter
002599

  • Light-cured dental restorative composite resin
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