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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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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

GC Reline ™ - D0470018591

GC Reline ™ 56 g (48 mL) cartridge (Ultra Soft)
Gc America Inc.
001859
Not in Commercial Distribution

  • D0470018591 ()

  • Weight: 56 Gram
001859

  • Denture reliner, elastic, short-term

GC Reline ™ - D0470006031

GC Reline ™ Modifier, 1-1 Pack, A&B 10 g (9 mL) each, mixing pad & sponge
Gc America Inc.
000603
Not in Commercial Distribution

  • D0470006032 ()
  • D0470006031 ()
000603

  • Denture reliner, elastic, short-term

GC Reline ™ - D0470006021

GC Reline ™ Primer R, 12 g (13 mL) liquid
Gc America Inc.
000602
Not in Commercial Distribution

  • D0470006022 ()
  • D0470006021 ()

  • Weight: 12 Gram
000602

  • 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

NATURE-CRYL® - D6583498071

NATURE-CRYL® SUPER HI IMPACT ORIGINAL 1lb POWDER
Gc America Inc.
349807
Not in Commercial Distribution

  • D6583498071 ()

  • Weight: 1 Pound
349807

  • Denture reliner, hard

NATURE-CRYL® - D6583498061

NATURE-CRYL® SUPER HI IMPACT LIGHT REDDISH PINK 1lb POWDER
Gc America Inc.
349806
Not in Commercial Distribution

  • D6583498061 ()

  • Weight: 1 Pound
349806

  • Denture reliner, hard

NATURE-CRYL® - D6583498051

NATURE-CRYL® SUPER HI IMPACT LIGHT 1lb POWDER
Gc America Inc.
349805
Not in Commercial Distribution

  • D6583498051 ()

  • Weight: 1 Pound
349805

  • Denture reliner, hard

NATURE-CRYL® - D6583498041

NATURE-CRYL® SUPER HI IMPACT HEAVY 1lb POWDER
Gc America Inc.
349804
Not in Commercial Distribution

  • D6583498041 ()

  • Weight: 1 Pound
349804

  • Denture reliner, hard

NATURE-CRYL® - D6583498031

NATURE-CRYL® SUPER HI IMPACT MODERATE 1lb POWDER
Gc America Inc.
349803
Not in Commercial Distribution

  • D6583498031 ()

  • Weight: 1 Pound
349803

  • Denture reliner, hard

NATURE-CRYL® - D6583498021

NATURE-CRYL® SUPER HI IMPACT MILD 1lb POWDER
Gc America Inc.
349802
Not in Commercial Distribution

  • D6583498021 ()

  • Weight: 1 Pound
349802

  • Denture reliner, hard

NATURE-CRYL® - D6583498011

NATURE-CRYL® SUPER HI IMPACT LIGHT FIBERED + 1lb POWDER
Gc America Inc.
349801
Not in Commercial Distribution

  • D6583498011 ()

  • Weight: 1 Pound
349801

  • Denture reliner, hard

NATURE-CRYL® - D6583497561

NATURE-CRYL® POUR ORIGINAL 1lb POWDER
Gc America Inc.
349756
Not in Commercial Distribution

  • D6583497561 ()

  • Weight: 1 Pound
349756

  • Denture reliner, hard

NATURE-CRYL® - D6583497551

NATURE-CRYL® POUR LIGHT REDDISH PINK 1lb POWDER
Gc America Inc.
349755
Not in Commercial Distribution

  • D6583497551 ()

  • Weight: 1 Pound
349755

  • Denture reliner, hard

NATURE-CRYL® - D6583497541

NATURE-CRYL® POUR LIGHT 1lb POWDER
Gc America Inc.
349754
Not in Commercial Distribution

  • D6583497541 ()

  • Weight: 1 Pound
349754

  • Denture reliner, hard

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

Park Dental Research Corp. - D769JCH10

JUELL Cure Hard
PARK DENTAL RESEARCH CORP
JCH-1
Not in Commercial Distribution

  • D769JCH10 ()


  • Denture reliner, hard

IMTEC - D76987200

IMTEC Cure Hard by JUELL
PARK DENTAL RESEARCH CORP
8720
In Commercial Distribution

  • D76987200 ()


  • Denture reliner, hard

GC Reline ™ - 10386040007085

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

  • 10386040007085 ()
346094

  • Denture reliner, elastic, short-term

GC Reline ™ - 10386040007078

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

  • 10386040007078 ()
346001

  • Denture reliner, elastic, short-term

COE-RECT™ - 10386040006934

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

  • 10386040006934 ()
343092

  • Denture reliner, hard

COE-RECT™ - 10386040006927

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

  • 10386040006927 ()
343091

  • Denture reliner, hard

COE-RECT™ - 10386040006910

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

  • 10386040006910 ()
343002

  • Denture reliner, hard
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