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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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Comspan® Opaque Composite Luting Cement Complete Package
DENTSPLY INTERNATIONAL INC.
655275
In Commercial Distribution

  • D0026552751 ()

  • 1 Jar Base Paste, 1 Jar Catalyst Paste, 1 Bottle Tooth Cond Gel, 1 Bottle Bonding Base, 1 Bottle Bonding Catalyst, 1 Dispensing Well, 1 Mixing Pad, 6 Mixing Sticks, 1 Brush Handle, 40 Brush Tips
  • Weight: 5 Gram
655275

  • Dental composite resin
Compspan™ Composite Luting Cement Complete Package
DENTSPLY INTERNATIONAL INC.
655100
In Commercial Distribution

  • D0026551001 ()

  • Weight: 5 Gram
  • 1 base paste, 1 catalyst paste, 1 self-cure bonding agent base liquid, 1 self-cure bonding agent catalyst liquid, 1 bottle tooth conditioner gel, and accessories
655100

  • Dental composite resin
Prisma® VLC Dycal® Visible Light Cure Base/Liner Composition Standard Package
DENTSPLY INTERNATIONAL INC.
654502
In Commercial Distribution

  • D0026545021 ()

  • Weight: 4 Gram
  • 2 Tubes Prisma® VLC Dycal® (4g), 1 Transfer Pad
654502

  • Dental composite resin
Esthet-X®flow Liquid Micro Hybrid Compula® Tips Introductory Kit
DENTSPLY INTERNATIONAL INC.
648101
Not in Commercial Distribution

  • D0026481011 ()

  • 24 Tips, 1 Tips Gun, 1 Syringe Tooth Cond Gel, 25 Applicator Needles, 20 Unit Doses Adhesive, 1 Unit Dose Holder, 20 Applicator Tips, Enhance Finishing Sample, Polishing Sample, Tips Sample
  • Weight: 0.25 Gram
648101

  • Dental composite resin
Esthet-X® Flow Liquid Micro Hybrid Baggie Sample - Shade A2
DENTSPLY INTERNATIONAL INC.
648002
Not in Commercial Distribution

  • D0026480020 ()

  • Weight: 0.65 Gram
  • Esthet-X® Flow 1/2 filled Syringe (Shade A2) and 3 Syringe Tips
648002

  • Dental composite resin
Esthet-X®flow Liquid Micro Hybrid Syringe Introductory Kit
DENTSPLY INTERNATIONAL INC.
648001
Not in Commercial Distribution

  • D0026480011 ()

  • Weight: 1.3 Gram
  • 7 Syringes, 30 Gray Tips, 1 Syringe Dyract®flow, 6 Black Tips, 20 Unit Doses Adhesive, 1 Unit Dose Holder, 20 Microbrushes, 1 Syringe Tooth Conditioner Gel, 25 Applicator Needles, and 20 Microbrushes
648001

  • Dental composite resin
SureFil® High Density Posterior Restorative Refill Package, Syringe, Shade C, 1 (3g)
DENTSPLY INTERNATIONAL INC.
645231
In Commercial Distribution

  • D0026452310 ()

  • Weight: 3 Gram
  • 1 Syringe (3g) Shade C
645231

  • Dental composite resin
SureFil® High Density Posterior Restorative Refill Package, Syringe, Shade B, 1 (3g)
DENTSPLY INTERNATIONAL INC.
645221
In Commercial Distribution

  • D0026452210 ()

  • 1 Syringe (3g) Shade B
  • Weight: 3 Gram
645221

  • Dental composite resin
SureFil® High Density Posterior Restorative Refill Package, Syringe, Shade A, 1 (3g)
DENTSPLY INTERNATIONAL INC.
645211
In Commercial Distribution

  • D0026452110 ()

  • Weight: 3 Gram
  • 1 Syringe (3g) Shade A
645211

  • 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
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