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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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EXAFLEX® - D6581384011

EXAFLEX® Monophase (purple) Standard Packs (1 x 74mL base, 1 x 74mL catalyst, 1 x mixing pad)
Gc America Inc.
138401
In Commercial Distribution

  • D6581384012 ()
  • D6581384011 ()
138401

  • Silicone dental impression material

EXAFLEX® - D6581383011

EXAFLEX® Putty 1-1 Pack (1 x 500g blue base Jar, 1 x 500g yellow catalyst Jar, 2 x scoops)
Gc America Inc.
138301
In Commercial Distribution

  • D6581383012 ()
  • D6581383011 ()
138301

  • Silicone dental impression material

EXAFLEX® - D6581381011

EXAFLEX® Injection (pink) Standard Packs (1 x 74mL base, 1 x 74mL catalyst, 1 x mixing pad)
Gc America Inc.
138101
In Commercial Distribution

  • D6581381012 ()
  • D6581381011 ()
138101

  • Silicone dental impression material

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™ - 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

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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