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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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EXAMIX™ - D6581371061

EXAMIX™ NDS Injection (copper) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
Gc America Inc.
137106
In Commercial Distribution

  • D6581371062 ()
  • D6581371061 ()
137106

  • Silicone dental impression material

EXAMIX™ - D6581370161

EXAMIX™ NDS Regular (blue) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
Gc America Inc.
137016
In Commercial Distribution

  • D6581370162 ()
  • D6581370161 ()
137016

  • Silicone dental impression material

EXAlence™ - D6581370141

EXA’lence™ Fast Set 48mL Cartridge Heavy Body (Dark Green), 4 x cartridges, 12 x mixing tips
Gc America Inc.
137014
In Commercial Distribution

  • D6581370142 ()
  • D6581370141 ()

  • Total Volume: 48 Milliliter
137014

  • Silicone dental impression material

EXAFAST™ - D6581370071

EXAFAST™ NDS Regular (blue) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
Gc America Inc.
137007
In Commercial Distribution

  • D6581370072 ()
  • D6581370071 ()
137007

  • Silicone dental impression material

FREEGENOL™ - D6581365011

FREEGENOL™ Standard Package (55g base, 20g catalyst, & mixing pad)
Gc America Inc.
136501
In Commercial Distribution

  • D6581365012 ()
  • D6581365011 ()
136501

  • Fatty acid dental cement

NOGENOL™ - D6581364021

NOGENOL™ Temporary Cement Standard Package (2 x 30g base, 1 x 65g catalyst)
Gc America Inc.
136402
Not in Commercial Distribution

  • D6581364022 ()
  • D6581364021 ()
136402

  • Fatty acid dental cement

COE-PAK™ - D6581353011

COE-PAK™ Hard and Fast Set (1 x 90g Base & 1 x 90g catalyst)
Gc America Inc.
135301
In Commercial Distribution

  • D6581353012 ()
  • D6581353011 ()
135301

  • Clinical periodontal dressing

COE-PAK™ - D6581350011

COE-PAK™ Regular Set (1 x 90g base & 1 x 90g catalyst)
Gc America Inc.
135001
In Commercial Distribution

  • D6581350012 ()
  • D6581350011 ()
135001

  • Clinical periodontal dressing

COE-FLEX® - D6581311051

COE-FLEX® s Regular Body, Fast Set (1 x 90mL base, 1 x 45mL catalyst)
Gc America Inc.
131105
In Commercial Distribution

  • D6581311052 ()
  • D6581311051 ()
131105

  • Polyether dental impression material

COE-FLEX® - D6581311041

COE-FLEX® s Heavy Body (1 x 90mL base, 1 x 45mL catalyst)
Gc America Inc.
131104
In Commercial Distribution

  • D6581311042 ()
  • D6581311041 ()
131104

  • Polyether dental impression material
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