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

  • D6584245052 ()
  • D6584245051 ()
424505

  • Dental coating, tooth-desensitizing
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™ 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™ 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
COE-COMFORT™ Professional Package (1 x 6oz powder, 1 x 6oz liquid and accessories)
Gc America Inc.
341001
In Commercial Distribution

  • D6583410012 ()
  • D6583410011 ()
341001

  • Denture reliner, elastic, short-term
UNIFAST™ Trad 260mL liquid
Gc America Inc.
339292
In Commercial Distribution

  • D6583392922 ()
  • D6583392921 ()

  • Total Volume: 260 Milliliter
339292

  • Temporary dental crown/bridge resin
UNIFAST™ Trad 104mL liquid
Gc America Inc.
339291
In Commercial Distribution

  • D6583392912 ()
  • D6583392911 ()

  • Total Volume: 104 Milliliter
339291

  • Temporary dental crown/bridge resin
UNIFAST™ Trad 8 Live Pink, 250g powder
Gc America Inc.
339115
In Commercial Distribution

  • D6583391152 ()
  • D6583391151 ()

  • Weight: 250 Gram
339115

  • Temporary dental crown/bridge resin
UNIFAST™ Trad Ivory, 250g powder
Gc America Inc.
339114
In Commercial Distribution

  • D6583391142 ()
  • D6583391141 ()

  • Weight: 250 Gram
339114

  • Temporary dental crown/bridge resin
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