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

  • D6583382032 ()
  • D6583382031 ()
338203

  • Temporary dental crown/bridge resin
UNIFAST™ LC C2, 50g powder
Gc America Inc.
338122
In Commercial Distribution

  • D6583381222 ()
  • D6583381221 ()
338122

  • Temporary dental crown/bridge resin
UNIFAST™ LC B3, 50g powder
Gc America Inc.
338113
In Commercial Distribution

  • D6583381132 ()
  • D6583381131 ()
338113

  • Temporary dental crown/bridge resin
UNIFAST™ LC B2, 50g powder
Gc America Inc.
338112
In Commercial Distribution

  • D6583381122 ()
  • D6583381121 ()
338112

  • Temporary dental crown/bridge resin
UNIFAST™ LC A3, 50g powder
Gc America Inc.
338103
In Commercial Distribution

  • D6583381032 ()
  • D6583381031 ()
338103

  • Temporary dental crown/bridge resin
UNIFAST™ LC A2, 50g powder
Gc America Inc.
338102
In Commercial Distribution

  • D6583381022 ()
  • D6583381021 ()
338102

  • Temporary dental crown/bridge resin
EXAFLEX® Regular (blue) Standard Packs (1 x 74mL base, 1 x 74mL catalyst, 1 x mixing pad)
Gc America Inc.
138901
In Commercial Distribution

  • D6581389012 ()
  • D6581389011 ()
138901

  • Silicone dental impression material
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® 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
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
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