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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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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

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

COE-COMFORT™ - 10386040000840

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

  • 10386040000840 ()

  • Weight: 170 Gram
341002

  • Denture reliner, elastic, short-term

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

GC Reline ™ - 10386040000871

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

  • 10386040000871 ()
346191

  • 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

MucoHard™ - 00810000525690

MucoHard™+ Primer Refill
PARKELL, INC.
S642
In Commercial Distribution

  • 00810000525690 ()
S642

  • Denture reliner, hard

MucoHard™ - 00810000525683

MucoHard™+ Cartridge Refill
PARKELL, INC.
S641
In Commercial Distribution

  • 00810000525683 ()
S641

  • Denture reliner, hard

MucoHard™ - 00810000525676

MucoHard™+ Kit
PARKELL, INC.
S640
In Commercial Distribution

  • 00810000525676 ()
S640

  • Denture reliner, hard

Acrylic Solder™ - 00810000529636

500ml Bottle of Bonding Liner for Acrylic Solder™
PARKELL, INC.
S815
In Commercial Distribution

  • 00810000529636 ()
S815

  • Denture reliner, hard

MucoHard™ - 00810000525270

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

  • 00810000525270 ()
S487

  • Denture reliner, hard

MucoHard™ - 00810000525263

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

  • 00810000525263 ()
S486

  • Denture reliner, hard

MucoHard™ - 00810000525256

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

  • 00810000525256 ()
S485

  • Denture reliner, hard

Novocol EXACTON SOFT CHRSD RELINE PWD/LIQ - 07540187001474

No Description
SEPTODONT, INC
FP-NOVOINC-126
In Commercial Distribution

  • 07540187001474 ()


  • Denture reliner, elastic, short-term

Novocol EXACTON HARD CHRSD RELINE PWD/LIQ - 07540187001450

No Description
SEPTODONT, INC
FP-NOVOINC-125
In Commercial Distribution

  • 07540187001450 ()


  • Denture reliner, elastic, short-term

Novocol EXACTON CHAIRSIDE RELINE POWDER 100G - 07540187001467

No Description
SEPTODONT, INC
FP-NOVOINC-127
In Commercial Distribution

  • 07540187001467 ()


  • Denture reliner, elastic, short-term

PROVISA - D74446343990

PROVISA RELINE HARD ADHES 10ML
BENCO DENTAL SUPPLY CO.
4634-399
In Commercial Distribution

  • D74446343990 ()


  • Denture reliner, hard

PROVISA - D74446343800

PROVISA RELINE HARD 1:1 REF
BENCO DENTAL SUPPLY CO.
4634-380
In Commercial Distribution

  • D74446343800 ()


  • Denture reliner, hard

PROVISA - D74446343710

PROVISA RELINE HRD 1:1 KIT
BENCO DENTAL SUPPLY CO.
4634-371
In Commercial Distribution

  • D74446343710 ()


  • Denture reliner, hard

PROVISA - D74446115650

PROVISA RELINE GLAZE REF BT
BENCO DENTAL SUPPLY CO.
4611-565
In Commercial Distribution

  • D74446115650 ()


  • Denture reliner, elastic, long-term

PROVISA - D74446115560

PROVISA CEM RELINE ADH REF BT
BENCO DENTAL SUPPLY CO.
4611-556
In Commercial Distribution

  • D74446115560 ()


  • Denture reliner, elastic, long-term

PROVISA - D74446115470

PROVISA CEM SFT RELINE CART RF
BENCO DENTAL SUPPLY CO.
4611-547
In Commercial Distribution

  • D74446115470 ()


  • Denture reliner, elastic, long-term

PROVISA - D74446115380

PROVISA CEM RELINE CART SFT KT
BENCO DENTAL SUPPLY CO.
4611-538
In Commercial Distribution

  • D74446115380 ()


  • Denture reliner, elastic, long-term

Tuf-Link II - 07350081494810

TUF-LINK 10 ml syringe Silicone Material incl. 3 mixing tips for TK-G-10 Dispenser Gun
Dentatus AB
TK-102
In Commercial Distribution

  • 07350081494810 ()
TK-102

  • Denture reliner, elastic, long-term

Tuf-Link II - 07350081494827

TUF-LINK 50 ml syringe Silicone Material incl. 10 mixing tips for TK-G Dispenser Gun.
Dentatus AB
TK-502
In Commercial Distribution

  • 07350081494827 ()
TK-502

  • Denture reliner, elastic, long-term

Mucopren - E217281061

Mucopren Soft Basic Set + Applyfix 4 disp. gun
Kettenbach GmbH & Co. KG
28106
In Commercial Distribution

  • E217281061 ()
28106

  • Denture reliner, elastic, long-term

Mucopren - E217281051

Mucopren Soft Basic Set
Kettenbach GmbH & Co. KG
28105
In Commercial Distribution

  • E217281051 ()
28105

  • Denture reliner, elastic, long-term

Mucopren - E217156871

Mucopren Soft Normal pack
Kettenbach GmbH & Co. KG
15687
In Commercial Distribution

  • E217156871 ()
15687

  • Denture reliner, elastic, long-term

Mucopren - E217156861

Mucopren silicone sealant Normal pack
Kettenbach GmbH & Co. KG
15686
In Commercial Distribution

  • E217156861 ()
15686

  • Denture reliner, elastic, long-term

Mucopren - E217142031

Mucopren Adhesive
Kettenbach GmbH & Co. KG
14203
In Commercial Distribution

  • E217142031 ()
14203

  • Denture reliner, elastic, long-term

CediTEC - E22160821

Luting of prefabricated prosthetic teeth in denture basis, repair and extension of dental prosthesis
VOCO GmbH
6082
In Commercial Distribution

  • E22160821 ()
6082

  • Denture reliner, hard

Ufi Gel hard C - E22122181

Hard direct denture relining. The kit contains set + dispenser cartridge 80 g, adhesive bottle 10 ml and accessories.
VOCO GmbH
2218
In Commercial Distribution

  • E22122181 ()
2218

  • Denture reliner, hard
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