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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™ 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
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
Lynal® Tissue Conditioner & Temporary Reliner Package
DENTSPLY INTERNATIONAL INC.
653006
In Commercial Distribution

  • D0026530060 ()

  • Total Volume: 90 Milliliter
  • Weight: 120 Gram
  • 1 Powder (120g), 1 Liquid (90 mL), 1 Separator (15mL), and Accessories
653006

  • Denture reliner, soft, professional
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