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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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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

COE-RECT™ - 10386040006903

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

  • 10386040006903 ()
343001

  • Denture reliner, hard

GC Reline ™ - 10386040003766

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

  • 10386040003766 ()
346002

  • Denture reliner, elastic, short-term

KOOLINER™ - 10386040003759

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

  • 10386040003759 ()
345091

  • Denture reliner, hard

KOOLINER™ - 10386040003742

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

  • 10386040003742 ()
345002

  • Denture reliner, hard

COE-SOFT™ - 10386040003735

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

  • 10386040003735 ()
344094

  • Denture reliner, elastic, short-term

COE-COMFORT™ - 10386040003667

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

  • 10386040003667 ()

  • Total Volume: 6 Fluid Ounce
341091

  • Denture reliner, elastic, short-term

GC Reline ™ - 10386040000871

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

  • 10386040000871 ()
346191

  • Denture reliner, elastic, short-term

COE-COMFORT™ - 10386040000840

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

  • 10386040000840 ()

  • Weight: 170 Gram
341002

  • Denture reliner, elastic, short-term

KOOLINER™ - 10386040000352

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

  • 20386040000359 ()
  • 10386040000352 ()
345001

  • Denture reliner, hard

COE-COMFORT™ - 10386040000338

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

  • 20386040000335 ()
  • 10386040000338 ()
341001

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLUS12L0

ProTech Plus Kit Shade Clear - 440 g ProTech Plus Powder and 240 ml ProTech Plus Monomer
PROTECH PROFESSIONAL PRODUCTS INC
PLUS12L
In Commercial Distribution

  • D814PLUS12L0 ()
PLUS12L

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLUS12GD0

ProTech Plus Shade 506RR 440 g Powder Only
PROTECH PROFESSIONAL PRODUCTS INC
PLUS12GD
In Commercial Distribution

  • D814PLUS12GD0 ()
PLUS12GD

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLUS12GA0

ProTech Plus 440 g Powder Only Shade 1069LO
PROTECH PROFESSIONAL PRODUCTS INC
PLUS12GA
In Commercial Distribution

  • D814PLUS12GA0 ()
PLUS12GA

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLUS12F0

240 ml ProTech Plus Monomer
PROTECH PROFESSIONAL PRODUCTS INC
PLUS12F
In Commercial Distribution

  • D814PLUS12F0 ()
PLUS12F

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLUS12AC0

ProTech Plus Kit Shade 1060LL - 440 g ProTech Plus Powder and 240 ml ProTech Plus Monomer
PROTECH PROFESSIONAL PRODUCTS INC
PLUS12AC
In Commercial Distribution

  • D814PLUS12AC0 ()
PLUS12AC

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLUS120

ProTech Plus Kit Shade JP - 440 g ProTech Plus Powder and 240 ml ProTech Plus Monomer
PROTECH PROFESSIONAL PRODUCTS INC
PLUS12
In Commercial Distribution

  • D814PLUS120 ()
PLUS12

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLU15GD1

4.5 kg ProTech Plus Hard Reline and Repair Acrylic Shade 506RR
PROTECH PROFESSIONAL PRODUCTS INC
PLU15GD
Not in Commercial Distribution

  • D814PLU15GD1 ()
PLU15GD

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLU15GA1

4.5 kg ProTech Plus Hard Reline and Repair Acrylic Shade 1069LO
PROTECH PROFESSIONAL PRODUCTS INC
PLU15GA
Not in Commercial Distribution

  • D814PLU15GA1 ()
PLU15GA

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLU15F1

4 Liter ProTech Plus Hard Reline and Repair Acrylic Monomer
PROTECH PROFESSIONAL PRODUCTS INC
PLU15F
Not in Commercial Distribution

  • D814PLU15F1 ()
PLU15F

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLU14GD1

4.5 kg ProTech Plus Hard Reline and Repair Acrylic Shade 506RR
PROTECH PROFESSIONAL PRODUCTS INC
PLU14GD
Not in Commercial Distribution

  • D814PLU14GD1 ()
PLU14GD

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLU14GA1

4.5 kg ProTech Plue Hard Reline and Repair Acrylic Shade 1069LO
PROTECH PROFESSIONAL PRODUCTS INC
PLU14GA
Not in Commercial Distribution

  • D814PLU14GA1 ()
PLU14GA

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLU13GL1

2.25 kg ProTech Plus Hard Reline and Repair Acrylic Shade Clear
PROTECH PROFESSIONAL PRODUCTS INC
PLU13GL
Not in Commercial Distribution

  • D814PLU13GL1 ()
PLU13GL

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLU12GC1

440 gram ProTech Plus Hard Reline and Repair Acrylic Shade 1060LL
PROTECH PROFESSIONAL PRODUCTS INC
PLU12GC
Not in Commercial Distribution

  • D814PLU12GC1 ()
PLU12GC

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLU12GA1

440 gram ProTech Plus Hard Reline and Repair Acrylic Shade 1069LO
PROTECH PROFESSIONAL PRODUCTS INC
PLU12GA
Not in Commercial Distribution

  • D814PLU12GA1 ()
PLU12GA

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLU12G1

440 gram ProTech Plus Hard Reline and Repair Acrylic Shade JP
PROTECH PROFESSIONAL PRODUCTS INC
PLU12G
Not in Commercial Distribution

  • D814PLU12G1 ()
PLU12G

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLU12F1

240 ml ProTech Plus Hard Reline and Repair Acrylic Monomer
PROTECH PROFESSIONAL PRODUCTS INC
PLU12F
Not in Commercial Distribution

  • D814PLU12F1 ()
PLU12F

  • Denture reliner, elastic, short-term

ProTech Plus Hard Reline and Repair Acrylic - D814PLU12D1

ProTech Plus Hard Reline and Repair Acrylic Kit - 440 gram powder Shade 506RR and 240 ml monomer
PROTECH PROFESSIONAL PRODUCTS INC
PLU12D
Not in Commercial Distribution

  • D814PLU12D1 ()
PLU12D

  • Denture reliner, elastic, short-term
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