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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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Algin-X® Ultra Alginate Alternative - D00261E8021

Algin-X® Ultra Alginate Alternative Sampler
DENTSPLY INTERNATIONAL INC.
61E802
In Commercial Distribution

  • D00261E8021 ()

  • 1 Algin-X® Ultra Cartridge (50mL) and 2 Mixing Tips
  • Total Volume: 50 Milliliter
61E802

  • Silicone dental impression material

Algin-X™ Ultra Alginate Alternative - D00261E8011

Algin-X™ Ultra Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
61E801
In Commercial Distribution

  • D00261E8010 ()
  • D00261E8011 ()
61E801

  • Silicone dental impression material

Algin-X™ Ultra Alginate Alternative - D00261E8001

Algin-X™ Ultra Alginate Alternative Impression Material, Fast Set, 4 (50ml) Cartridge Refill
DENTSPLY INTERNATIONAL INC.
61E800
In Commercial Distribution

  • D00261E80082 ()
  • D00261E8001 ()
  • D00261E8000 ()

  • Total Volume: 50 Milliliter
  • 4 Algin-X™ Ultra Cartridges (50mL each) and 6 Mixing Tips
61E800

  • Silicone dental impression material

SDR® Plus Bulk Fill Flowable - D00261C130P1

SDR® Plus Syringe Refill
DENTSPLY INTERNATIONAL INC.
61C130P
In Commercial Distribution

  • D00261C130P0 ()
  • D00261C130P1 ()
61C130P

  • Dental composite resin

SDR® Plus Bulk Fill Flowable - D00261C111P1

SDR® Plus Syringe Tips Refill
DENTSPLY INTERNATIONAL INC.
61C111P
In Commercial Distribution

  • D00261C111P0 ()
  • D00261C111P1 ()

  • 60 Syringe Tips
61C111P

  • Dental material mixing nozzle

SDR® flow+ Bulk Fill Flowable - D00261C111G1

SDR® flow+ Syringe Tips Refill
DENTSPLY INTERNATIONAL INC.
61C111G
In Commercial Distribution

  • D00261C111G0 ()
  • D00261C111G1 ()

  • 60 Syringe Tips
61C111G

  • Dental material mixing nozzle

SDR® Plus Bulk Fill Flowable - D00261C108P1

SDR® Plus Compula Refill - Shade A3
DENTSPLY INTERNATIONAL INC.
61C108P
In Commercial Distribution

  • D00261C108P0 ()
  • D00261C108P1 ()
61C108P

  • Dental composite resin

SDR® Plus Bulk Fill Flowable - D00261C107P1

SDR® Plus Compula Refill - Shade A2
DENTSPLY INTERNATIONAL INC.
61C107P
In Commercial Distribution

  • D00261C107P0 ()
  • D00261C107P1 ()
61C107P

  • Dental composite resin

SDR® Plus Bulk Fill Flowable - D00261C106P1

SDR® Plus Compula Refill - Shade A1
DENTSPLY INTERNATIONAL INC.
61C106P
In Commercial Distribution

  • D00261C106P0 ()
  • D00261C106P1 ()
61C106P

  • Dental composite resin

SDR® Plus Bulk Fill Flowable - D00261C104P1

SDR® Plus Bulk Fill Flowable
DENTSPLY INTERNATIONAL INC.
61C104P
In Commercial Distribution

  • D00261C104P1 ()

  • 1 Syringe (1 g), 3 Syringe Tips
61C104P

  • Dental composite resin

SDR® Plus Bulk Fill Flowable - D00261C103P1

SDR® Plus Compula ECO Refill
DENTSPLY INTERNATIONAL INC.
61C103P
In Commercial Distribution

  • D00261C103P0 ()
  • D00261C103P1 ()
61C103P

  • Dental composite resin

SDR® Plus Bulk Fill Flowable - D00261C101P1

SDR® Plus Compula Refill - Shade Universal
DENTSPLY INTERNATIONAL INC.
61C101P
In Commercial Distribution

  • D00261C101P0 ()
  • D00261C101P1 ()
61C101P

  • Dental composite resin

Calm-it™ Desensitizer - D00261A1001

Calm-it™ Unit Dose Sample
DENTSPLY INTERNATIONAL INC.
61A100
Not in Commercial Distribution

  • D00261A1001 ()

  • 1 Calm-it™ Desensitizer Unit Dose
61A100

  • Dental cavity varnish

Regisil® Rigid Super Fast Set Cartridge System - D0026194251

Regisil® Rigid Super Fast Set VPS Bite Reg Material (Purple), Cartridge System Refill Package
DENTSPLY INTERNATIONAL INC.
619425
In Commercial Distribution

  • D00261942582 ()
  • D0026194251 ()
  • D0026194250 ()

  • Total Volume: 50 Milliliter
  • 4 Cartridges (50mL each), 12 Mixing Tips
619425

  • Silicone dental impression material

FluoroCore® 2+ Dual Cure Core Build-up Material + Fast Endodontic Post Cement - D0026126001

FluoroCore® 2+ Introductory Kit
DENTSPLY INTERNATIONAL INC.
612600
In Commercial Distribution

  • D0026126001 ()
612600

  • Dental composite resin

FluoroCore® 2+ Dual Cure Core Build-Up Material + Fast Endodontic Post Cement - D0026124061

FluoroCore® 2+ Evaluator Kit
DENTSPLY INTERNATIONAL INC.
612406
In Commercial Distribution

  • D0026124061 ()

  • 1 Syringe (tooth colored), 10 Intraoral Tips, 10 Mixing Tips, 10 Endo Intraoral Tips
612406

  • 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
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