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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® - D0470014201

GRADIA® FOUNDATION OPAQUE
Gc America Inc.
001420
In Commercial Distribution

  • D0470014202 ()
  • D0470014201 ()
001420

  • Light-cured dental restorative composite resin

GRADIA® - D0470014191

GRADIA® MASTER SET 10 SHADES
Gc America Inc.
001419
In Commercial Distribution

  • D0470014192 ()
  • D0470014191 ()
001419

  • Light-cured dental restorative composite resin

GC Reline ™ - D0470006031

GC Reline ™ Modifier, 1-1 Pack, A&B 10 g (9 mL) each, mixing pad & sponge
Gc America Inc.
000603
Not in Commercial Distribution

  • D0470006032 ()
  • D0470006031 ()
000603

  • Denture reliner, elastic, short-term

GC Reline ™ - D0470006021

GC Reline ™ Primer R, 12 g (13 mL) liquid
Gc America Inc.
000602
Not in Commercial Distribution

  • D0470006022 ()
  • D0470006021 ()

  • Weight: 12 Gram
000602

  • Denture reliner, elastic, short-term

GC Reline ™ - D0470006011

GC Reline ™ Extra soft 56 g (48 mL) cartridge
Gc America Inc.
000601
Not in Commercial Distribution

  • D0470006012 ()
  • D0470006011 ()

  • Weight: 56 Gram
000601

  • Denture reliner, elastic, short-term

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 Reline ™ - D0470005991

GC Reline ™ Soft 62 g (48 mL) cartridge
Gc America Inc.
000599
Not in Commercial Distribution

  • D0470005992 ()
  • D0470005991 ()

  • Weight: 62 Gram
000599

  • Denture reliner, elastic, short-term

GC Reline ™ - D0470005981

GC Reline ™ Soft Intro Package 1 (48mL) cartridge, 6 type 2L mixing tips, 13mL bottle of Primer R, 1 silicone point, 9mL bottles of Reline Modifier Parts A & B, mixing pad, pellet sponges, spatula, scoop and brush.
Gc America Inc.
000598
Not in Commercial Distribution

  • D0470005982 ()
  • D0470005981 ()
000598

  • 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

UNIFAST™ - D0470003681

UNIFAST™LC 2 x 14.7 mL liquid btl
Gc America Inc.
000368
In Commercial Distribution

  • D0470003682 ()
  • D0470003681 ()

  • Total Volume: 14.7 Milliliter
000368

  • Temporary dental crown/bridge resin
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