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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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NATURE-CRYL® - D6583497011

NATURE-CRYL® HI-20ET COE-LOR MILD 1lb POWDER
Gc America Inc.
349701
Not in Commercial Distribution

  • D6583497011 ()

  • Weight: 1 Pound
349701

  • Denture reliner, hard

GC Reline ™ - D6583461911

GC Reline ™ 50mL liquid
Gc America Inc.
346191
In Commercial Distribution

  • D6583461911 ()
346191

  • Denture reliner, elastic, short-term

GC Reline ™ - D6583460941

GC Reline ™ Bonding Agent, 12g
Gc America Inc.
346094
In Commercial Distribution

  • D6583460941 ()
346094

  • Denture reliner, elastic, short-term

GC Reline ™ - D6583460021

GC Reline ™ 80g powder
Gc America Inc.
346002
In Commercial Distribution

  • D6583460021 ()
346002

  • Denture reliner, elastic, short-term

GC Reline ™ - D6583460011

GC Reline ™ Intro Package, Standard Package Powder/ Liquid (1 x 80g powder, 1 x 50mL liquid, 1 x 12g Bonding Agent & accessories)
Gc America Inc.
346001
In Commercial Distribution

  • D6583460011 ()
346001

  • Denture reliner, elastic, short-term

KOOLINER™ - D6583450911

KOOLINER™ 2oz liquid
Gc America Inc.
345091
In Commercial Distribution

  • D6583450911 ()
345091

  • Denture reliner, hard

KOOLINER™ - D6583450021

KOOLINER™ 3oz powder
Gc America Inc.
345002
In Commercial Distribution

  • D6583450021 ()
345002

  • Denture reliner, hard

KOOLINER™ - D6583450011

KOOLINER™ Professional Package (1 x 3oz powder, 1 x 2oz liquid and accessories)
Gc America Inc.
345001
In Commercial Distribution

  • D6583450012 ()
  • D6583450011 ()
345001

  • Denture reliner, hard

COE-SOFT™ - D6583440941

COE-SOFT™ 18mL lubricant
Gc America Inc.
344094
In Commercial Distribution

  • D6583440941 ()
344094

  • Denture reliner, elastic, short-term

COE-RECT™ - D6583430921

COE-RECT™ 14mL repair liquid
Gc America Inc.
343092
In Commercial Distribution

  • D6583430921 ()
343092

  • Denture reliner, hard
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