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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™ - D6583381021

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

  • D6583381022 ()
  • D6583381021 ()
338102

  • Temporary dental crown/bridge resin

EXAFLEX® - D6581389011

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® - 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® - D6581382011

EXAFLEX® Heavy (yellow) Standard Packs (1 x 74mL base, 1 x 74mL catalyst, 1 x mixing pad)
Gc America Inc.
138201
In Commercial Distribution

  • D6581382012 ()
  • D6581382011 ()
138201

  • 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

Alpine Dental - D922VPSAD3110

Vinyl Polysiloxane Impression Cartridge, Heavy Body, Regular Set, 50ml (1)
ALPINE DENTAL INC.
AD311
In Commercial Distribution

  • D922VPSAD3101 ()
  • D922VPSAD3110 ()
VPSAD311

  • Silicone dental impression material

Alpine Dental - D922VPSAD3010

Vinyl Polysiloxane Impression Cartridge, Heavy Body, Fast Set, 50ml (1)
ALPINE DENTAL INC.
AD301
In Commercial Distribution

  • D922VPSAD3010 ()
  • D922VPSAD3001 ()
VPSAD301

  • Silicone dental impression material

Alpine Dental - D922VPSAD1011

Vinyl Polysiloxane Impression Cartridge, Injection, Fast Set, 50ml (1)
ALPINE DENTAL INC.
AD101
In Commercial Distribution

  • D922VPSAD1011 ()
  • D922VPSAD1001 ()
VPSAD101

  • Silicone dental impression material

Alpine Dental - D922BRAD6160

Bite Registration Cartridge, Fast Set, 50ml (1)
ALPINE DENTAL INC.
AD616
In Commercial Distribution

  • D922BRAD6151 ()
  • D922BRAD6160 ()
BRAD616

  • Silicone dental impression material
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