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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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FluoroCore® Flouride-Releasing, Dual Cure Build-Up Material - D0026123001

FluoroCore® Complete Package
DENTSPLY INTERNATIONAL INC.
612300
Not in Commercial Distribution

  • D0026123001 ()

  • FluoroCore S/C Activator, Prime & Bond NT, FluoroCore Blue Base, FluoroCore T-Color Base, FluoroCore Catalyst, FluoroCore A/C Activator (4.5mL), and accessories
  • Weight: 4.5 Gram
612300

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070690

Calibra® Esthetic Resin Cement, Catalyst, High Viscosity 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607069
In Commercial Distribution

  • D0026070690 ()

  • 1 Syringe Calibra® Catalyst (2g), High Viscosity
  • Weight: 2 Gram
607069

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070680

Calibra® Esthetic Resin Cement, Catalyst, Regular Viscosity, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607068
In Commercial Distribution

  • D0026070680 ()

  • 1 Syringe Calibra® Catalyst (2g), Regular Viscosity
  • Weight: 2 Gram
607068

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070640

Calibra® Esthetic Resin Cement, Base, Translucent, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607064
In Commercial Distribution

  • D0026070640 ()

  • 1 Syringe Calibra® Base Shade (2g), Translucent
  • Weight: 2 Gram
607064

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070630

Calibra® Esthetic Resin Cement, Base, Dark, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607063
In Commercial Distribution

  • D0026070630 ()

  • 1 Syringe Calibra® Base Shade (2g), Dark
  • Weight: 2 Gram
607063

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070620

Calibra® Esthetic Resin Cement, Base, Medium, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607062
In Commercial Distribution

  • D0026070620 ()

  • 1 Syringe Calibra® Base Shade (2g), Medium
  • Weight: 2 Gram
607062

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070610

Calibra® Esthetic Resin Cement, Base, Light, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607061
In Commercial Distribution

  • D0026070610 ()

  • 1 Syringe Calibra® Base Shade (2g), Light
  • Weight: 2 Gram
607061

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070601

Calibra® Esthetic Resin Cement 2-Part Complete System Kit
DENTSPLY INTERNATIONAL INC.
607060
Not in Commercial Distribution

  • D0026070601 ()

  • 5 Syringe Base 2g ea, 5 Syringes Catalyst 2g ea, 5 Syringes Try-In Paste 1.8g ea, 1 Adhesive 4.5mL, 1 Activator 4.5mL, 1 Coupling agent 3mL, 1 Syringe Tooth Conditioner 3mL, and accessories
607060

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070591

Calibra® Esthetic Resin Cement Operatory Kit
DENTSPLY INTERNATIONAL INC.
607059
Not in Commercial Distribution

  • D0026070591 ()

  • 25 Disposable Applicator Tips, 1 Mixing Stick, 1 Brush Handle, 40 Disposable Brush Tips, 1 Dispensing Well, 1 Mixing Pad, 1 Light Protection Cover
607059

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070561

Calibra® Esthetic Resin Cement Sampler
DENTSPLY INTERNATIONAL INC.
607056
Not in Commercial Distribution

  • D0026070561 ()

  • 1 Dual Cure Automix Syringe, 5 Mixing Tips
  • Weight: 4.5 Gram
607056

  • Dental composite resin
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