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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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SDR® Plus Bulk Fill Flowable - D010606030481

SDR® Plus Collectors Edition
DENTSPLY INTERNATIONAL INC.
60603048
In Commercial Distribution

  • D010606030481 ()
60603048

  • Dental composite resin

SDR® Plus Bulk Fill Flowable - D010606030471

SDR® Plus Compula Intro Kit
DENTSPLY INTERNATIONAL INC.
60603047
In Commercial Distribution

  • D010606030471 ()
60603047

  • Dental composite resin

SDR® Plus Bulk Fill Flowable - D010606030451

SDR® Plus Syringe ECO Refill
DENTSPLY INTERNATIONAL INC.
60603045
In Commercial Distribution

  • D010606030450 ()
  • D010606030451 ()
60603045

  • Dental composite resin

B4® Pre-Impression Surface Optimizer - D0026781320

B4® Pre-Impression Surface Optimizer Refill
DENTSPLY INTERNATIONAL INC.
678132
In Commercial Distribution

  • D0026781320 ()

  • 1 Bottle B4® (6mL), 1 Dispensing Well, 50 Flocked Applicator Tips
678132

  • Silicone dental impression material

Aquasil Ultimate Tissue Managing Tray Impression System DECA™ - D0026780591

Aquasil Ultra Cordless Tissue Managing Impression System Tray (Light Green) 2 (380ml) DECA™ Cartridge Standard Pack
DENTSPLY INTERNATIONAL INC.
678059
In Commercial Distribution

  • D00267805932 ()
  • D0026780591 ()
  • D0026780590 ()

  • 2 DECA™ cartridges, 20 Mixing Tips, 1 Bayonet Ring
  • Total Volume: 380 Milliliter
678059

  • Silicone dental impression material

Aquasil Ultimate Tissue Managing Tray Impression System - D0026780561

Aquasil Ultimate Tissue Managing Tray Impression System Cartridge Refill (Light Green)
DENTSPLY INTERNATIONAL INC.
678056
In Commercial Distribution

  • D00267805682 ()
  • D0026780561 ()
  • D0026780560 ()

  • Total Volume: 50 Milliliter
  • 4 (50ml) Cartridges Refill, 12 Mixing Tips (Green)
678056

  • Silicone dental impression material

Aquasil Ultimate Tissue Managing Wash Impression System - D002678053K1

Aquasil Ultimate digit power® 15 pk Multi Refill with B4
DENTSPLY INTERNATIONAL INC.
678053K
In Commercial Distribution

  • D002678053K1 ()

  • 15 Digit Power Wash Material Cartridges, 15 Digit Power Mixing Tips with Intraoral Tips, 1 Bottle B4 Pre-Impression Surface Optimizer, 1 Dispensing Well, 25 Flocked Applicator Tips
  • Total Volume: 1.6 Milliliter
  • Total Volume: 6 Milliliter
678053K

  • Silicone dental impression material

Aquasil Ultimate Tissue Managing Wash Impression System - D0026780531

Aquasil Ultra Cordless Tissue Managing Impression System Wash (Light Blue) w/B4™ digit power Multi 15 (1.60ml) Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678053
In Commercial Distribution

  • D0026780531 ()

  • Total Volume: 6 Milliliter
  • 15 Digit Power Wash Material Cartridges, 15 Digit Power Mixing Tips with Intraoral Tips, 1 Bottle B4™ Pre-Impression Surface Optimizer, 1 Dispensing Well, 25 Flocked Applicator Tips
  • Total Volume: 1.6 Milliliter
678053

  • Silicone dental impression material

Aquasil Ultimate Tissue Managing Wash Impression System - D0026780501

Aquasil Ultra Cordless Tissue Managing Impression System Wash (Light Purple) w/B4™ digit power Single 50 (0.68ml) Cartridges Single Refill
DENTSPLY INTERNATIONAL INC.
678050
In Commercial Distribution

  • D0026780501 ()

  • Total Volume: 0.68 Milliliter
  • Total Volume: 6 Milliliter
  • 50 Digit Power Wash Material Cartridges, 50 Digit Power Mixing Tips with Intraoral Tips, 1 Bottle B4™ Pre-Impression Surface Optimizer, 1 Dispensing Well, 50 Flocked Applicator Tips
678050

  • Silicone dental impression material

Aquasil® Ultra+ digit® Smart Wetting® Impression Material - D0026780341

Aquasil® Ultra+ digit® LV/XLV Fast Set Evaluator Kit
DENTSPLY INTERNATIONAL INC.
678034
In Commercial Distribution

  • D0026780341 ()
  • D0026780340 ()

  • Total Volume: 1.6 Milliliter
  • 6 (1.6mL) small cartridges, 6 mixing tips, 6 intraoral tips, 1 syringe dispenser
678034

  • Silicone dental impression material
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