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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® - D6583497531

NATURE-CRYL® POUR COE-LOR HEAVY 1lb POWDER
Gc America Inc.
349753
Not in Commercial Distribution

  • D6583497531 ()

  • Weight: 1 Pound
349753

  • Denture reliner, hard

NATURE-CRYL® - D6583497521

NATURE-CRYL® POUR MODERATE 1lb POWDER
Gc America Inc.
349752
Not in Commercial Distribution

  • D6583497521 ()

  • Weight: 1 Pound
349752

  • Denture reliner, hard

NATURE-CRYL® - D6583497511

NATURE-CRYL® POUR COE-LOR MILD 1lb POWDER
Gc America Inc.
349751
Not in Commercial Distribution

  • D6583497511 ()

  • Weight: 1 Pound
349751

  • Denture reliner, hard

NATURE-CRYL® - D6583497501

NATURE-CRYL® POUR COE LIGHT FIBERED + 1lb POWDER
Gc America Inc.
349750
Not in Commercial Distribution

  • D6583497501 ()

  • Weight: 1 Pound
349750

  • Denture reliner, hard

NATURE-CRYL® - D6583497061

NATURE-CRYL® HI-20ET ORIGINAL 1lb POWDER
Gc America Inc.
349706
Not in Commercial Distribution

  • D6583497061 ()

  • Weight: 1 Pound
349706

  • Denture reliner, hard

NATURE-CRYL® - D6583497051

NATURE-CRYL® HI-20ET LIGHT REDDISH PINK 1lb POWDER
Gc America Inc.
349705
Not in Commercial Distribution

  • D6583497051 ()

  • Weight: 1 Pound
349705

  • Denture reliner, hard

NATURE-CRYL® - D6583497041

NATURE-CRYL® HI-20ET LIGHT 1lb POWDER
Gc America Inc.
349704
Not in Commercial Distribution

  • D6583497041 ()

  • Weight: 1 Pound
349704

  • Denture reliner, hard

NATURE-CRYL® - D6583497021

NATURE-CRYL® HI-20ET COE-LOR MODERATE 1Ib POWDER
Gc America Inc.
349702
Not in Commercial Distribution

  • D6583497021 ()

  • Weight: 1 Pound
349702

  • Denture reliner, hard

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

NATURE-CRYL® - D6583497001

NATURE-CRYL® HI-20ET COE LIGHT FIBERED + 1Ib POWDER
Gc America Inc.
349700
Not in Commercial Distribution

  • D6583497001 ()

  • Weight: 1 Pound
349700

  • 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

COE-RECT™ - D6583430911

COE-RECT™ 6oz liquid
Gc America Inc.
343091
In Commercial Distribution

  • D6583430911 ()
343091

  • Denture reliner, hard

COE-RECT™ - D6583430021

COE-RECT™ 6oz powder
Gc America Inc.
343002
In Commercial Distribution

  • D6583430021 ()
343002

  • Denture reliner, hard

COE-RECT™ - D6583430011

COE-RECT™ Professional Package (1 x 6oz powder, 1 x 6oz liquid, 1 x 14mL repair liquid & accessories)
Gc America Inc.
343001
In Commercial Distribution

  • D6583430011 ()
343001

  • Denture reliner, hard

COE-COMFORT™ - D6583410911

COE-COMFORT™ 6oz liquid
Gc America Inc.
341091
In Commercial Distribution

  • D6583410911 ()

  • Total Volume: 6 Fluid Ounce
341091

  • Denture reliner, elastic, short-term

COE-COMFORT™ - D6583410021

COE-COMFORT™ 6oz powder
Gc America Inc.
341002
In Commercial Distribution

  • D6583410021 ()

  • Weight: 170 Gram
341002

  • Denture reliner, elastic, short-term

COE-COMFORT™ - D6583410011

COE-COMFORT™ Professional Package (1 x 6oz powder, 1 x 6oz liquid and accessories)
Gc America Inc.
341001
In Commercial Distribution

  • D6583410012 ()
  • D6583410011 ()
341001

  • Denture reliner, elastic, short-term

GC Reline ™ - D0470006011

GC Reline ™ Extra soft 56 g (48 mL) cartridge
Gc America Inc.
000601
Not in Commercial Distribution

  • D0470006012 ()
  • D0470006011 ()

  • Weight: 56 Gram
000601

  • Denture reliner, elastic, short-term

GC Reline ™ - D0470006001

GC Reline ™ Extra Soft Intro Package 1 (48mL) cartridge of extra soft, 6 type 2L mixing tips, 13mL bottle of Primer R, 1 silicone point, 9mL bottles of Reline Modifier Parts A 7 B, mixing pad, pellet sponges, spatula, scoop and brush
Gc America Inc.
000600
Not in Commercial Distribution

  • D0470006002 ()
  • D0470006001 ()
000600

  • Denture reliner, elastic, short-term

GC Reline ™ - D0470005991

GC Reline ™ Soft 62 g (48 mL) cartridge
Gc America Inc.
000599
Not in Commercial Distribution

  • D0470005992 ()
  • D0470005991 ()

  • Weight: 62 Gram
000599

  • Denture reliner, elastic, short-term

GC Reline ™ - D0470005981

GC Reline ™ Soft Intro Package 1 (48mL) cartridge, 6 type 2L mixing tips, 13mL bottle of Primer R, 1 silicone point, 9mL bottles of Reline Modifier Parts A & B, mixing pad, pellet sponges, spatula, scoop and brush.
Gc America Inc.
000598
Not in Commercial Distribution

  • D0470005982 ()
  • D0470005981 ()
000598

  • Denture reliner, elastic, short-term

Henry Schein - 00304040029459

Softline RELINE 100G Powder 100gm Bt
HENRY SCHEIN, INC.
2912322
In Commercial Distribution

  • 00304040029459 ()

  • Bottle
  • Weight: 100 Gram
2912322

  • Denture reliner, elastic, short-term

Henry Schein - 00304040029435

Chairside Reline Material Pack Ea
HENRY SCHEIN, INC.
1005646
In Commercial Distribution

  • 00304040029435 ()

  • Bottle
  • Total Volume: 110 Milliliter
  • Weight: 100 Gram
1005646

  • Denture reliner, elastic, short-term

Henry Schein - 00304040029428

Softline Chairside Reline Material Pk
HENRY SCHEIN, INC.
1003029
In Commercial Distribution

  • 00304040029428 ()

  • Bottle
  • Weight: 100 Gram
  • Total Volume: 110 Milliliter
1003029

  • Denture reliner, elastic, short-term

Sofreliner Tough - 04548190234417

Primer
TOKUYAMA DENTAL CORPORATION
23441
In Commercial Distribution

  • 04548190234417 ()


  • Denture reliner, elastic, long-term

Sofreliner Tough - 04548190233564

M Paste
TOKUYAMA DENTAL CORPORATION
23356
In Commercial Distribution

  • 04548190233564 ()


  • Denture reliner, elastic, long-term

Sofreliner Tough - 04548190233519

M Kit
TOKUYAMA DENTAL CORPORATION
23351
In Commercial Distribution

  • 04548190233519 ()


  • Denture reliner, elastic, long-term

TOKUYAMA REBASE - 04548190206636

Adhesive
TOKUYAMA DENTAL CORPORATION
20663
In Commercial Distribution

  • 04548190206636 ()


  • Denture reliner, hard

TOKUYAMA REBASE III - 04548190206629

Liquid
TOKUYAMA DENTAL CORPORATION
20662
In Commercial Distribution

  • 04548190206629 ()


  • Denture reliner, hard

TOKUYAMA REBASE III - 04548190206612

Fast, Powder, Light Pink
TOKUYAMA DENTAL CORPORATION
20661
In Commercial Distribution

  • 04548190206612 ()


  • Denture reliner, hard

TOKUYAMA REBASE III - 04548190206605

Fast, Kit, Light Pink
TOKUYAMA DENTAL CORPORATION
20660
In Commercial Distribution

  • 04548190206605 ()


  • Denture reliner, hard

Tokuyama Rebase II - 04548190205639

Adhesive
TOKUYAMA DENTAL CORPORATION
20563
In Commercial Distribution

  • 04548190205639 ()


  • Denture reliner, hard
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