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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® 2+ Dual Cure Core Build-Up Material + Fast Endodontic Post Cement - D0026124001

FluoroCore® 2+ Dual Cure Core Build-Up Material + Fast Endodontic Post Cement Introductory Kit
DENTSPLY INTERNATIONAL INC.
612400
Not in Commercial Distribution

  • D0026124001 ()

  • Weight: 4.75 Gram
  • 2 Tooth Colored Syringes, 2 Blue Syringes, 1 bottle each Xeno®, P&B, and activator, 25 Mixing Tips, 25 Intraoral Tips, 10 Endo Intaoral Tips, 1 Disp Well, 50 App Tips, 50 Root Canal Tips
612400

  • Dental composite resin

FluoroCore® Flouride-Releasing, Dual Cure Build-Up Material - D0026123101

FluoroCore® Starter Pack
DENTSPLY INTERNATIONAL INC.
612310
Not in Commercial Distribution

  • D0026123101 ()

  • Weight: 4.5 Gram
  • 1 syringe base, 1 syringe catalyst, P&B NT (2mL), Self Cure Activator (2mL), Brushes, Mix Tray, and accessories
612310

  • Dental composite resin

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® Abutment - D0026077010

Calibra® Abutment Resin Cement Sample
DENTSPLY INTERNATIONAL INC.
607701
In Commercial Distribution

  • D0026077010 ()

  • 1 Syringe (2g), 10 Mix Tips
607701

  • Dental composite resin

Calibra® Abutment - D0026077000

Calibra® Abutment Resin Cement Syringe Refill
DENTSPLY INTERNATIONAL INC.
607700
In Commercial Distribution

  • D0026077000 ()

  • 1 Syringe (4.5g), 10 Mix Tips
607700

  • Dental composite resin

Calibra® Veneer Esthetic Resin Cement - D0026075001

Calibra® Veneer Kit
DENTSPLY INTERNATIONAL INC.
607500
In Commercial Distribution

  • D0026075001 ()
607500

  • Dental composite resin

Calibra® Universal+ Versatile Resin Cement - D002607410NA1

Calibra® Universal+ Sample
DENTSPLY INTERNATIONAL INC.
607410NA
In Commercial Distribution

  • D002607410NA1 ()

  • 2 Syringes (4.5g each); 20 Mixing Tips
607410NA

  • Dental composite resin

Calibra® Universal Self-Adhesive Resin Cement - D0026074101

Calibra® Universal Sample Package
DENTSPLY INTERNATIONAL INC.
607410
In Commercial Distribution

  • D0026074101 ()

  • 1 Syringe (2g) and 10 Mixing Tips
607410

  • Dental composite resin

Calibra® Universal Self-Adhesive Resin Cement - D0026074001

Calibra® Universal Syringe Introductory Kit
DENTSPLY INTERNATIONAL INC.
607400
In Commercial Distribution

  • D0026074001 ()

  • 5 Dual Cure AutoMix Syringes (4.5g) - 1 each shade: Light, Medium, Translucent, Opaque, Bleach; 50 Mixing Tips
  • Weight: 4.5 Gram
607400

  • Dental composite resin

Calibra® Veneer Esthetic Resin Cement - D0026073001

Calibra® Veneer Cement Try-In Paste Accessory Pack
DENTSPLY INTERNATIONAL INC.
607300
In Commercial Distribution

  • D0026073001 ()

  • 5 Syringes Calibra® Veneer Try-In Paste (1.8g each) - 1 in each shade: Light, Medium, Dark, Opaque, Bleach
  • Weight: 1.8 Gram
607300

  • Dental composite resin
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