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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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GRADIA® DIRECT Flo - 2 syringes (1.5 g/0.8 mL per syringe) CV,& 4 tips
Gc America Inc.
002285
In Commercial Distribution

  • D0470022851 ()

  • Weight: 1.5 Gram
002285

  • Light-cured dental restorative composite resin
GRADIA® DIRECT Flo - 2 syringes (1.5 g/0.8 mL per syringe) AO3, & 4 tips
Gc America Inc.
002284
In Commercial Distribution

  • D0470022841 ()

  • Weight: 1.5 Gram
002284

  • Light-cured dental restorative composite resin
GRADIA® DIRECT Flo - 2 syringes (1.5 g/0.8 mL per syringe) A3.5, & 4 tips
Gc America Inc.
002281
In Commercial Distribution

  • D0470022811 ()

  • Weight: 1.5 Gram
002281

  • Light-cured dental restorative composite resin
GRADIA® DIRECT Flo - 2 syringes (1.5 g/0.8 mL per syringe) A3, & 4 tips
Gc America Inc.
002280
In Commercial Distribution

  • D0470022801 ()

  • Weight: 1.5 Gram
002280

  • Light-cured dental restorative composite resin
GRADIA® DIRECT Flo - 2 syringes (1.5 g/0.8 mL per syringe) A2, & 4 tips
Gc America Inc.
002279
In Commercial Distribution

  • D0470022791 ()

  • Weight: 1.5 Gram
002279

  • Light-cured dental restorative composite resin
GRADIA® DIRECT Flo - 2 syringes (1.5 g/0.8 mL per syringe) A1, & 4 tips
Gc America Inc.
002278
In Commercial Distribution

  • D0470022781 ()

  • Weight: 1.5 Gram
002278

  • Light-cured dental restorative composite resin
GC Fuji ORTHO™ (2 x 13.3 g (7.2 mL) cartridges & 1 x mixing pad)
Gc America Inc.
001888
In Commercial Distribution

  • D0470018881 ()

  • Weight: 13.3 Gram
001888

  • Glass ionomer dental cement
GC Fuji LINING™ (1 x 7 g (4.7 mL) cartridge, 1 x mixing pad)
Gc America Inc.
001887
In Commercial Distribution

  • D0470018871 ()

  • Weight: 7 Gram
001887

  • Dental cavity liner
Renamel Microfill Pediatric Kit include 5 (4 g) syringes of Renamel Microfill in the Tray.
COSMEDENT, INC.
607PED
In Commercial Distribution

  • D779607PED3 ()
607PED

  • Dental composite resin
Renamel Microhybrid Pedo Kit includes 5 (5 g) syringes of Renamel Microhybrid in the Tray.
COSMEDENT, INC.
606PED
In Commercial Distribution

  • D779606PED3 ()
606PED

  • Dental composite resin
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