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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

NA - M595S8150

500ml Bottle of Bonding Liner for Acrylic Solder
PARKELL, INC.
S815
Not in Commercial Distribution

  • M595S8150 ()
S815

  • Denture reliner, hard

MucoHard™ - M595S4870

MucoHard™ Hard Denture Reline Kit
PARKELL, INC.
S487
Not in Commercial Distribution

  • M595S4870 ()
S487

  • Denture reliner, hard

MucoHard™ - M595S4860

MucoHard™ Resin Refill Cartridge with Tips
PARKELL, INC.
S486
Not in Commercial Distribution

  • M595S4860 ()
S486

  • Denture reliner, hard

MucoHard™ - M595S4850

MucoHard™ Bonding Liner with 6-Brushes & 6-Pipettes
PARKELL, INC.
S485
Not in Commercial Distribution

  • M595S4850 ()
S485

  • Denture reliner, hard

Sinfony™ - 04035077001731

3M™ ESPE™ Sinfony™ Dentin-Material D A0 Shade Dispenser Refill, 49099
3M Deutschland GmbH
49099
In Commercial Distribution

  • 04035077001731 ()
  • 04035077017312 ()
49099

  • Denture reliner, hard

Sinfony™ - 04035077000840

3M™ ESPE™ Sinfony™ Opaque Dentin-Material DO 5 Green-Grey Shade Dispenser Refill, 49550
3M Deutschland GmbH
49550
In Commercial Distribution

  • 04035077000840 ()
  • 04035077017619 ()
49550

  • Denture reliner, hard

Sinfony™ - 04035077000819

3M™ ESPE™ Sinfony™ Opaque Dentin-Material DO 2 Brown Shade Dispenser Refill, 49520
3M Deutschland GmbH
49520
In Commercial Distribution

  • 04035077000819 ()
  • 04035077017589 ()
49520

  • Denture reliner, hard
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