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™ II Disposable Brush (6)
Gc America Inc.
010282
In Commercial Distribution

  • D0470102821 ()
010282

  • Denture reliner, soft, professional
GC RELINE™ II Wheel for Finishing (12)
Gc America Inc.
010279
In Commercial Distribution

  • D0470102791 ()
010279

  • Denture reliner, soft, professional
GC RELINE ™ II Point for Trimming (3)
Gc America Inc.
010276
In Commercial Distribution

  • D0470102761 ()
010276

  • Denture reliner, soft, professional
GC RELINE™ II Remover (for Resin): 1 x 5g (5.5mL)
Gc America Inc.
010274
In Commercial Distribution

  • D0470102741 ()
010274

  • Denture reliner, soft, professional
GC RELINE™ II Primer for Resin: 1 x 8g (10mL)
Gc America Inc.
010272
In Commercial Distribution

  • D0470102721 ()
010272

  • Denture reliner, soft, professional
GC RELINE™ II Finishing Material: 1 each A & B 10g(9mL)
Gc America Inc.
010270
In Commercial Distribution

  • D0470102701 ()
010270

  • Denture reliner, soft, professional
GC RELINE™ II Cartridge ExtraSoft: 1 x57g (48mL)
Gc America Inc.
010267
In Commercial Distribution

  • D0470102671 ()
010267

  • Denture reliner, soft, professional
GC RELINE™ II Cartridge Soft: 1 x 61g (48mL)
Gc America Inc.
010264
In Commercial Distribution

  • D0470102641 ()
010264

  • Denture reliner, soft, professional
GC RELINE™ II Intro Kit ExtraSoft contains: 1 GC RELINE II Cartridge ExtraSoft 57g (48mL), 1 GC RELINE II Primer for Resin 8g (10mL), 1 GC RELINE II Point for Trimming, 1 GC RELINE II Wheel for Finishing, 1 GC RELINE II Remover for Resin 5g(5.5mL), 6 pieces Mixing Tip II L, 3 disposable brushes, 1 plastic spatula
Gc America Inc.
010261
In Commercial Distribution

  • D0470102611 ()
010261

  • Denture reliner, soft, professional
GC RELINE™ II Intro Kit Soft contains: 1 GC RELINE II Cartridge Soft 61g(48mL), 1 GC RELINE II Primer for Resin 8g(10mL), 1 GC RELINE II Point for Trimming, 1 GC RELINE II Wheel for Finishing, 1 GC RELINE II Remover for Resin 5g(5.5mL), 6 pieces Mixing Tip II L, 3 Disposable brushes, 1 plastic spatula
Gc America Inc.
010258
In Commercial Distribution

  • D0470102581 ()
010258

  • Denture reliner, soft, professional
GC RELINE™ II Cartridge ExtraExtraSoft: 1 x 55g(48mL)
Gc America Inc.
010257
In Commercial Distribution

  • D0470102571 ()
010257

  • Denture reliner, soft, professional
GC RELINE II™ Intro Kit ExtraExtraSoft contains: 1 GC RELINE II cartridge ExtraExtraSoft 55g (48mL), 1 GC RELINE II Primer for Resin 8g (10mL), 1 GC RELINE II Point for Trimming, 1 GC Reline II Wheel for Finishing, 1 GC Reline II Remover for Resin 5g (5.5mL), 6 pieces Mixing Tip II L, 3 Disposable brushes, 1 Plastic spatula
Gc America Inc.
010256
In Commercial Distribution

  • D0470102561 ()
010256

  • Denture reliner, soft, professional
SUPER-SOFT™ Professional Package (1 x 6oz powder, 1 x 6oz liquid and mixing accessories)
Gc America Inc.
348001
In Commercial Distribution

  • D6583480011 ()
348001

  • Denture reliner, soft, professional
COE-SOFT™ 1qt liquid
Gc America Inc.
344092
In Commercial Distribution

  • D6583440921 ()

  • Total Volume: 1 Quart
344092

  • Denture reliner, soft, professional
COE-SOFT™ Liquid Refill 5.5oz
Gc America Inc.
344033
In Commercial Distribution

  • D6583440331 ()

  • Total Volume: 5.5 Fluid Ounce
344033

  • Denture reliner, soft, professional
COE-SOFT™ Powder 5.5oz
Gc America Inc.
344022
In Commercial Distribution

  • D6583440221 ()

  • Weight: 156 Gram
344022

  • Denture reliner, soft, professional
COE-SOFT™ 5.5oz Prof. Pkg (1 x 5.5oz powder, 1 x 5.5oz liquid, 18mL lubricant and accessories)
Gc America Inc.
344011
In Commercial Distribution

  • D6583440112 ()
  • D6583440111 ()
344011

  • Denture reliner, soft, professional
COE-SOFT™ Economy Package (1 x 5lb powder)
Gc America Inc.
344004
In Commercial Distribution

  • D6583440041 ()

  • Weight: 5 Pound
344004

  • Denture reliner, soft, professional
COE-SOFT™ Economy Package (1 x 5lb powder, 2 x qt liquid)
Gc America Inc.
344003
In Commercial Distribution

  • D6583440031 ()

  • Weight: 5 Pound
344003

  • Denture reliner, soft, professional
COE-COMFORT™ 1qt liquid
Gc America Inc.
341092
In Commercial Distribution

  • D6583410921 ()

  • Total Volume: 1 Quart
341092

  • Denture reliner, soft, professional
COE-COMFORT™ 5lb Jar powder
Gc America Inc.
341004
In Commercial Distribution

  • D6583410041 ()

  • Weight: 5 Pound
341004

  • Denture reliner, soft, professional
Hydro-Cast® Tissue Treatment 130g bottle Powder Only
Sultan Healthcare Inc
73020
In Commercial Distribution

  • D6870073020FG2 ()
  • D687730201 ()

  • Weight: 130 Gram


  • Denture reliner, soft, professional
Hydro-Cast® Tissue Treatment and Functional Impression Material 1x115mL Bottle Liquid
Sultan Healthcare Inc
73015
In Commercial Distribution

  • D6870073015FG2 ()
  • D687730151 ()

  • Total Volume: 115 Milliliter


  • Denture reliner, soft, professional
Hydro-Cast® Tissue Treatment and Functional Impression Material Standard Package 1x115mL Bottle Liquid, 1x130g Bottle Powder, 1x8mL Flow Replenisher
Sultan Healthcare Inc
73010
In Commercial Distribution

  • D6870073010FG2 ()
  • D687730101 ()

  • Total Volume: 8 Milliliter
  • Weight: 120 Gram
  • Total Volume: 115 Milliliter


  • Denture reliner, soft, professional
Henry Schein® Eugenol - 4 oz bottle
DENTSPLY INTERNATIONAL INC.
1710504FG
Not in Commercial Distribution

  • D6871710504FG2 ()
  • D6871710504FG0 ()

  • 12 Bottles (4 oz each)
  • Total Volume: 4 Fluid Ounce
1710504FG

  • Denture reliner, soft, professional
Superdent® Eugenol U.S.P. 4 oz.
DENTSPLY INTERNATIONAL INC.
1410504FG
Not in Commercial Distribution

  • D6871410504FG2 ()
  • D6871410504FG0 ()

  • Total Volume: 118 Milliliter
  • 12 Bottles (4 oz/118mL)
1410504FG

  • Denture reliner, soft, professional
Zinc Oxide U.S.P., Bottle, Powder 1lb
DENTSPLY INTERNATIONAL INC.
0011804FG
Not in Commercial Distribution

  • D6870011804FG2 ()
  • D6870011804FG0 ()

  • 1 Bottle (453.6 g)
  • Weight: 453.6 Gram
0011804FG

  • Denture reliner, soft, professional
Zinc Oxide U.S.P., Bottle, Powder 1.5 oz
DENTSPLY INTERNATIONAL INC.
0011803FG
Not in Commercial Distribution

  • D6870011803FG2 ()
  • D6870011803FG0 ()

  • Weight: 42.53 Gram
  • 1 Bottle (42.53 g)
0011803FG

  • Denture reliner, soft, professional
Sultan 4 oz. Eugenol U.S.P.
DENTSPLY INTERNATIONAL INC.
0010504FG
Not in Commercial Distribution

  • D6870010504FG1 ()
  • D6870010504FG0 ()

  • Total Volume: 120 Milliliter
  • 12 bottles (120ml) of Eugenol U.S.P.
0010504FG

  • Denture reliner, soft, professional
RESILIENT DENTURE RELINE ACRYLIC RESIN LIQUID
LANG DENTAL MANUFACTURING CO., INC.
946 ML
In Commercial Distribution

  • D6501106R0 ()
1106R

  • Denture reliner, soft, professional
RESILIENT DENTURE RELINE ACRYLIC RESIN LIQUID
LANG DENTAL MANUFACTURING CO., INC.
118 ML
In Commercial Distribution

  • D6501103R0 ()
1103R

  • Denture reliner, soft, professional
CUSHION TREATMENT DENTURE REPAIR RELINE ACRYLIC RESIN POWDER
LANG DENTAL MANUFACTURING CO., INC.
11.3 KG PINK
In Commercial Distribution

  • D6501070PNK0 ()
1070PNK

  • Denture reliner, soft, professional
DENTURE RELINE ACRYLIC RESIN POWDER AND LIQUID
LANG DENTAL MANUFACTURING CO., INC.
SIX POUND PACKAGE PINK
Not in Commercial Distribution

  • D6500956PNK0 ()
0956PNK

  • Denture reliner, soft, professional
DENTURE RELINE ACRYLIC RESIN POWDER AND LIQUID
LANG DENTAL MANUFACTURING CO., INC.
SIX POUND PACKAGE CLEAR
Not in Commercial Distribution

  • D6500956CLR0 ()
0956CLR

  • Denture reliner, soft, professional
DENTURE RELINE ACRYLIC RESIN POWDER
LANG DENTAL MANUFACTURING CO., INC.
2.7 KG P1
In Commercial Distribution

  • D6500950P10 ()
0950P1

  • Denture reliner, soft, professional
DENTURE RELINE ACRYLIC RESIN POWDER
LANG DENTAL MANUFACTURING CO., INC.
2.7 KG F3
In Commercial Distribution

  • D6500950F30 ()
0950F3

  • Denture reliner, soft, professional
DENTURE RELINE ACRYLIC RESIN POWDER
LANG DENTAL MANUFACTURING CO., INC.
2.7 KG F1
In Commercial Distribution

  • D6500950F10 ()
0950F1

  • Denture reliner, soft, professional
DENTURE RELINE ACRYLIC RESIN POWDER AND LIQUID
LANG DENTAL MANUFACTURING CO., INC.
POUND PACKAGE PINK
In Commercial Distribution

  • D6500934PNK0 ()
0934PNK

  • Denture reliner, soft, professional
DENTURE RELINE ACRYLIC RESIN POWDER AND LIQUID
LANG DENTAL MANUFACTURING CO., INC.
POUND PACKAGE FIBRED PINK
In Commercial Distribution

  • D6500934FIB0 ()
0934FIB

  • Denture reliner, soft, professional
DENTURE RELINE ACRYLIC RESIN POWDER AND LIQUID
LANG DENTAL MANUFACTURING CO., INC.
POUND PACKAGE B1
In Commercial Distribution

  • D6500934B10 ()
0934B1

  • Denture reliner, soft, professional
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