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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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GC Fuji ORTHO™ - D6584395031

GC Fuji ORTHO™ Intro Package, 1-2 Pack (1 x 40g powder, 2 x 6.8mL liquid & accessories)
Gc America Inc.
439503
In Commercial Distribution

  • D6584395032 ()
  • D6584395031 ()
439503

  • Glass ionomer dental cement

GC Fuji ORTHO™ - D6584394501

GC Fuji ORTHO™ LC Box of 50 capsules (mixed volume per capsule 0.10mL)
Gc America Inc.
439450
In Commercial Distribution

  • D6584394502 ()
  • D6584394501 ()
  • D6584394500 ()
439450

  • Glass ionomer dental cement

GC Fuji ORTHO™ - D6584394031

GC Fuji ORTHO™ LC Standard Package (1 x 40g powder, 2 x 6.8mL liquid, 1 x scoop & 1 x mixing pad)
Gc America Inc.
439403
In Commercial Distribution

  • D6584394032 ()
  • D6584394031 ()
439403

  • Glass ionomer dental cement

GC Fuji ORTHO™ - D6584394011

GC Fuji ORTHO™ LC Introductory Package (1 x 15g powder, 1 x 6.8mL liquid, 1 x scoop & 1 x mixing pad)
Gc America Inc.
439401
In Commercial Distribution

  • D6584394012 ()
  • D6584394011 ()
439401

  • Glass ionomer dental cement

GC Fuji PLUS® - D6584310121

GC Fuji PLUS® 15g powder
Gc America Inc.
431012
In Commercial Distribution

  • D6584310122 ()
  • D6584310121 ()
431012

  • Glass ionomer dental cement

GC Fuji PLUS® - D6584310111

GC Fuji PLUS® 1:1 Kit (1 x 15g powder, 1 x 7mL liquid, 1 x GC Fuji PLUS CONDITIONER & accessories)
Gc America Inc.
431011
In Commercial Distribution

  • D6584310112 ()
  • D6584310111 ()
431011

  • Glass ionomer dental cement

MI Paste™ - D6584245051

MI Paste™ 10-pack, 10 tubes (40g each) Strawberry only
Gc America Inc.
424505
In Commercial Distribution

  • D6584245052 ()
  • D6584245051 ()
424505

  • Dental coating, tooth-desensitizing

MI Paste™ - D6584222651

MI Paste™ 10-pack, 10 tubes (40g each) of MI Paste Assorted has 2 tubes of each flavor (melon, mint, strawberry, tutti-frutti & vanilla)
Gc America Inc.
422265
In Commercial Distribution

  • D6584222652 ()
  • D6584222651 ()
422265

  • Dental coating, tooth-desensitizing

KOOLINER™ - D6583450011

KOOLINER™ Professional Package (1 x 3oz powder, 1 x 2oz liquid and accessories)
Gc America Inc.
345001
In Commercial Distribution

  • D6583450012 ()
  • D6583450011 ()
345001

  • Denture reliner, hard

COE-SOFT™ - D6583440111

COE-SOFT™ 5.5oz Prof. Pkg (1 x 5.5oz powder, 1 x 5.5oz liquid, 18mL lubricant and accessories)
Gc America Inc.
344011
In Commercial Distribution

  • D6583440112 ()
  • D6583440111 ()
344011

  • Denture reliner, soft, professional
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