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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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Dyract® eXtra Universal Compomer Restorative, A3.5, Compules® Tips Refill Package
DENTSPLY INTERNATIONAL INC.
685403
In Commercial Distribution

  • D0026854031 ()
  • D0026854030 ()

  • Weight: 0.25 Gram
  • 20 Dyract® eXtra Universal Compomer Restorative, A3.5, Compules® Tips
685403

  • Dental composite resin
Dyract® eXtra Universal Compomer Restorative, A3, Compules® Tips Refill Package
DENTSPLY INTERNATIONAL INC.
685402
In Commercial Distribution

  • D0026854021 ()
  • D0026854020 ()

  • 20 Dyract eXtra Universal Compomer Restorative, A3, Compules® Tips
  • Weight: 0.25 Gram
685402

  • Dental composite resin
Dyract® eXtra Universal Compomer Restorative, A2, Compules® Tips Refill Package
DENTSPLY INTERNATIONAL INC.
685401
In Commercial Distribution

  • D0026854011 ()
  • D0026854010 ()

  • Weight: 0.25 Gram
  • 20 Dyract® eXtra Universal Compomer Restorative, A2, Compules® Tips
685401

  • Dental composite resin
SureFil® High Density Posterior Restorative Introductory Kit
DENTSPLY INTERNATIONAL INC.
645003
Not in Commercial Distribution

  • D0026450031 ()

  • 5 Blisters of Each Size (1, 2, and 3 Spill) and each Shade (A, B, and C): 45 Blisters total Shade A- Red Lid, Shade B - Beige Lid, Shade C - Gray Lid, Accessories
  • Total Volume: 4.5 Milliliter
  • Total Volume: 3 Milliliter
645003

  • Dental composite resin
TPH®3 Micro Matrix Restorative Easy-Twist 1/2 Syringe Baggy Sample - Shade A2
DENTSPLY INTERNATIONAL INC.
642708
Not in Commercial Distribution

  • D0026427080 ()

  • Weight: 1 Gram
  • TPH®3 1/2-filled syringe (shade A2)
642708

  • Dental composite resin
TPH®3 Easy-Twist Syringe Introductory Kit
DENTSPLY INTERNATIONAL INC.
642706
Not in Commercial Distribution

  • D0026427061 ()

  • Weight: 3 Gram
  • Total Volume: 3 Milliliter
  • 8 TPH3 Syringes, 5 P&B Unit Doses, 1 Prisma Gloss Fine and Extrafine Syringe, 1 syringe Tooth Cond Gel, 1 shade guide, 25 polishing cups, 1 mandrel, Enhance Discs, Cups, & Points, 5 App Tips
642706

  • Dental composite resin
TPH®3 Compules® Tips Trial Kit
DENTSPLY INTERNATIONAL INC.
642702
Not in Commercial Distribution

  • D0026427021 ()

  • Compules gun, TPH®3 Compules, TPH®3 Shade Tabs, Prisma Gloss Fine and Extra Fine Syringes, and Accessories
  • Weight: 0.25 Gram
642702

  • Dental composite resin
TPH®3 Compules® Tips Intro System
DENTSPLY INTERNATIONAL INC.
642701
Not in Commercial Distribution

  • D0026427011 ()

  • 38 Compules Tips, 1 gun, 1 shade guide, 5 P&B Unit Doses, Discs, Cups, and Points, 1 syringe Tooth Cond Gel, 25 Needles, 1 Syringe Prisma Gloss Fine & Extrafine, 5 Tips, 25 Polishing Cups, 1 Mandrel
642701

  • Dental composite resin
TPH®3 Compules® Tips Complete Organizer System
DENTSPLY INTERNATIONAL INC.
642700
Not in Commercial Distribution

  • D0026427001 ()

  • 96 Compules Tips, 1 gun, 1 Shade Guide System, 1 syringe Tooth Cond Gel, 10 P&B Unit Doses, 1 syringe each of TPH3, Prisma Gloss Fine & Extrafine, Enhance Finishers, 1 Mandrel, Cups, Tips & Needles
642700

  • Dental composite resin
TPH Spectra® Universal Composite Restorative, HV Easy-Twist Syringe Refill, A4, 1 Syringe
DENTSPLY INTERNATIONAL INC.
642676
Not in Commercial Distribution

  • D0026426760 ()

  • Weight: 3 Gram
  • Easy-Twist Syringe (3g) Shade A4, Shade Label Color Pink
642676

  • Dental composite resin
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