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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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CERASMART® - D0470083651

CERASMART® (Cerec Size 14), Shade A2, High Translucency, 5 pieces
Gc America Inc.
008365
In Commercial Distribution

  • D0470083652 ()
  • D0470083651 ()
  • D0470083650 ()
008365

  • Dental implant suprastructure, permanent, preformed

CERASMART® - D0470083641

CERASMART® (Cerec Size 14), Shade A1, High Translucency, 5 pieces
Gc America Inc.
008364
In Commercial Distribution

  • D0470083642 ()
  • D0470083641 ()
  • D0470083640 ()
008364

  • Dental implant suprastructure, permanent, preformed

CERASMART® - D0470083631

CERASMART® for Planmill 12 Bleach 5 pieces
Gc America Inc.
008363
In Commercial Distribution

  • D0470083632 ()
  • D0470083631 ()
  • D0470083630 ()
008363

  • Dental implant suprastructure, permanent, preformed

CERASMART® - D0470083621

CERASMART® for Planmill 12 B1LT 5 pieces
Gc America Inc.
008362
In Commercial Distribution

  • D0470083622 ()
  • D0470083621 ()
  • D0470083620 ()
008362

  • Dental implant suprastructure, permanent, preformed

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
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