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 Primer for Resin: 1 x 8g (10mL)
Gc America Inc.
010272
In Commercial Distribution

  • 14548161321419 ()
010272

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

  • 14548161321396 ()
010267

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

  • 14548161321389 ()
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

  • 14548161321372 ()
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

  • 14548161321365 ()
010258

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

  • 14548161321358 ()
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

  • 14548161321341 ()
010256

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

  • 14548161321440 ()
010279

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

  • 14548161321433 ()
010276

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

  • 14548161321402 ()
010270

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

  • 00386040003714 ()

  • Weight: 5 Pound
344003

  • Denture reliner, soft, professional
ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures, meets ISO 10139-2, and is a Shors A hardness Type A material.
WHIP-MIX CORPORATION
Introduction Kit
Not in Commercial Distribution

  • D040200119303 ()
20011930

  • Denture reliner, soft, professional
ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures, meets ISO 10139-2, and is a Shors A hardness Type A material.
WHIP-MIX CORPORATION
Primer-15ml
Not in Commercial Distribution

  • D040200118701 ()

  • 15 ml
20011870

  • Denture reliner, soft, professional
ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures, meets ISO 10139-2, and is a Shors A hardness Type A material.
WHIP-MIX CORPORATION
Silicone Tube 12 oz.
Not in Commercial Distribution

  • D040200118602 ()

  • 12 oz.
20011860

  • Denture reliner, soft, professional
ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures, meets ISO 10139-2, and is a Shors A hardness Type A material.
WHIP-MIX CORPORATION
Silicone Tube 4 oz.
Not in Commercial Distribution

  • D040200118501 ()

  • 4 oz.
20011850

  • Denture reliner, soft, professional
VISCO GEL Standard Pack is a self-curing, resilient methacrylate formulation, intended for use as a limited-term soft linig material for complet and partial dentures. Visco-gel is received in 2 components powder (D010K2006000) and liquid (D010K3006010) both of them in a bottle delivery. With an additional bottle of a separator (D010K3006020) and its supporting accessories (Mixing Bowl, Powder Measure and Liquid Measure) it can be classified as a convenience kit.
Dentsply De Trey GmbH
61605002
In Commercial Distribution

  • D010616050021 ()

  • Weight: 120 Gram
  • Liquid
  • Total Volume: 15 Milliliter
  • Total Volume: 90 Milliliter
  • Powder
61605002

  • 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
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
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
OTC Primer 1.5ml Bottle
PARKELL, INC.
S826
Not in Commercial Distribution

  • M595S8260 ()
S826

  • Denture reliner, soft, professional
MucoSoft® Bonding Liner (Adhesive)
PARKELL, INC.
S494
Not in Commercial Distribution

  • M595S4940 ()
S494

  • Denture reliner, soft, professional
MucoSoft® Glaze (Bottles A & B)
PARKELL, INC.
S493
Not in Commercial Distribution

  • M595S4930 ()
S493

  • Denture reliner, soft, professional
Refill MucoSoft® Reline Silicone: (1 Cartridge & 10 Tips)
PARKELL, INC.
S492S
Not in Commercial Distribution

  • M595S492S0 ()
S492S

  • Denture reliner, soft, professional
MucoSoft® Soft Denture Reline Kit
PARKELL, INC.
S491S
Not in Commercial Distribution

  • M595S491S0 ()
S491S

  • Denture reliner, soft, professional
Chairside Soft Reline Material
Zest Anchors, LLC
09573
In Commercial Distribution

  • 00840481111778 ()

  • Weight: 52 Gram
  • Total Volume: 10 Milliliter
09573

  • Denture reliner, soft, professional
Zest Anchors Dual Cure Denture Luting Material, 18mL Cartridge
Zest Anchors, LLC
09565
In Commercial Distribution

  • 00840481118975 ()

  • Total Volume: 18 Milliliter


  • Denture reliner, soft, professional
Cartridge [Chairside Soft Reline]
Zest Anchors, LLC
09573-01
In Commercial Distribution

  • 00840481117954 ()

  • Weight: 52 Gram
09573-01

  • Denture reliner, soft, professional
Prime [Chairside Soft Reline]
Zest Anchors, LLC
09573-02
In Commercial Distribution

  • 00840481117947 ()

  • Total Volume: 10 Milliliter
09573-02

  • Denture reliner, soft, professional
Varnish Catalyst for Silk Line Denture Reline
J. MORITA U.S.A., INC
Silk Line Varnish Catalyst
Not in Commercial Distribution

  • 10852253006172 ()


  • Denture reliner, soft, professional
Varnish Base for Silk Line Denture Reliner
J. MORITA U.S.A., INC
Silk Line Varnish Base
Not in Commercial Distribution

  • 10852253006165 ()


  • Denture reliner, soft, professional
Primer for Silk Line Denture Reliner
J. MORITA U.S.A., INC
28100300
In Commercial Distribution

  • 10852253006158 ()


  • Denture reliner, soft, professional
Refill Cartridge for Silk Line Denture Reliner
J. MORITA U.S.A., INC
28100200
In Commercial Distribution

  • 10852253006141 ()


  • Denture reliner, soft, professional
Soft Denture Relining Material
J. MORITA U.S.A., INC
28100100
In Commercial Distribution

  • 10852253006134 ()


  • Denture reliner, soft, professional
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