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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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UNIFAST™ - D6583391031

UNIFAST™ Trad Pink X, 100g powder
Gc America Inc.
339103
In Commercial Distribution

  • D6583391032 ()
  • D6583391031 ()

  • Weight: 100 Gram
339103

  • Temporary dental crown/bridge resin

UNIFAST™ - D6583391021

UNIFAST™ Trad 3 Pink, 100g powder
Gc America Inc.
339102
In Commercial Distribution

  • D6583391022 ()
  • D6583391021 ()

  • Weight: 100 Gram
339102

  • Temporary dental crown/bridge resin

UNIFAST™ - D6583382031

UNIFAST™ LC Translucent, 50g powder
Gc America Inc.
338203
In Commercial Distribution

  • D6583382032 ()
  • D6583382031 ()
338203

  • Temporary dental crown/bridge resin

UNIFAST™ - D6583381221

UNIFAST™ LC C2, 50g powder
Gc America Inc.
338122
In Commercial Distribution

  • D6583381222 ()
  • D6583381221 ()
338122

  • Temporary dental crown/bridge resin

UNIFAST™ - D6583381131

UNIFAST™ LC B3, 50g powder
Gc America Inc.
338113
In Commercial Distribution

  • D6583381132 ()
  • D6583381131 ()
338113

  • Temporary dental crown/bridge resin

UNIFAST™ - D6583381121

UNIFAST™ LC B2, 50g powder
Gc America Inc.
338112
In Commercial Distribution

  • D6583381122 ()
  • D6583381121 ()
338112

  • Temporary dental crown/bridge resin

UNIFAST™ - D6583381031

UNIFAST™ LC A3, 50g powder
Gc America Inc.
338103
In Commercial Distribution

  • D6583381032 ()
  • D6583381031 ()
338103

  • Temporary dental crown/bridge resin

UNIFAST™ - D6583381021

UNIFAST™ LC A2, 50g powder
Gc America Inc.
338102
In Commercial Distribution

  • D6583381022 ()
  • D6583381021 ()
338102

  • Temporary dental crown/bridge resin

EXAlence™ - D6581374441

EXA’lence™ Regular Set 48mL Cartridge Medium Body (Purple), 4 x cartridges, 12 x mixing tips
Gc America Inc.
137444
In Commercial Distribution

  • D6581374442 ()
  • D6581374441 ()
137444

  • Silicone dental impression material

EXAFAST™ - D6581374071

EXAFAST™ NDS Monophase (purple) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
Gc America Inc.
137407
In Commercial Distribution

  • D6581374072 ()
  • D6581374071 ()
137407

  • Silicone dental impression material

EXAMIX™ - D6581374061

EXAMIX™ NDS Monophase (purple) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
Gc America Inc.
137406
In Commercial Distribution

  • D6581374062 ()
  • D6581374061 ()
137406

  • Silicone dental impression material

EXAlence™ - D6581374041

EXA’lence™ Fast Set 48mL Cartridge Medium Body (Purple), 4 x cartridges, 12 x mixing tips
Gc America Inc.
137404
In Commercial Distribution

  • D6581374042 ()
  • D6581374041 ()
137404

  • Silicone dental impression material

EXAlence™ - D6581373341

EXA’lence™ Regular Set 48mL Cartridge Light Body (Pink), 4 x cartridges, 12 x mixing tips
Gc America Inc.
137334
In Commercial Distribution

  • D6581373342 ()
  • D6581373341 ()
137334

  • Silicone dental impression material

EXAlence™ - D6581373041

EXA’lence™ Fast Set 48mL Cartridge Light Body (Pink), 4 x cartridges, 12 x mixing tips
Gc America Inc.
137304
In Commercial Distribution

  • D6581373042 ()
  • D6581373041 ()
137304

  • Silicone dental impression material

OMNIFLEX™ - D6581373011

OMNIFLEX™ Standard Set (1 x 90mL base, 1 x 45mL catalyst, 1 x 15mL adhesive)
Gc America Inc.
137301
In Commercial Distribution

  • D6581373012 ()
  • D6581373011 ()
137301

  • Polyether dental impression material

EXAFAST™ - D6581372751

EXAFAST™ NDS Heavy (yellow) 75mL Package (2 x 75mL cartridges and 9 x mixing tips)
Gc America Inc.
137275
In Commercial Distribution

  • D6581372752 ()
  • D6581372751 ()

  • Total Volume: 75 Milliliter
137275

  • Silicone dental impression material

EXAlence™ - D6581372241

EXA’lence™ Regular Set 48mL Cartridge Extra Light Body (Yellow), 4 x cartridges, 12 x mixing tips
Gc America Inc.
137224
In Commercial Distribution

  • D6581372242 ()
  • D6581372241 ()
137224

  • Silicone dental impression material

EXAFAST™ - D6581372071

EXAFAST™ NDS Heavy (yellow) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
Gc America Inc.
137207
In Commercial Distribution

  • D6581372072 ()
  • D6581372071 ()

  • Total Volume: 48 Milliliter
137207

  • Silicone dental impression material

EXAMIX™ - D6581372061

EXAMIX™ NDS Heavy (yellow) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
Gc America Inc.
137206
In Commercial Distribution

  • D6581372062 ()
  • D6581372061 ()
137206

  • Silicone dental impression material

EXAlence™ - D6581372041

EXA’lence™ Fast Set 48mL Cartridge Extra Light Body (Yellow), 4 x cartridges, 12 x mixing tips
Gc America Inc.
137204
In Commercial Distribution

  • D6581372042 ()
  • D6581372041 ()
137204

  • Silicone dental impression material
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