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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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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

Aquasil® Ultra+ digit® Smart Wetting® Impression Material - D0026780331

Aquasil® Ultra+ digit® LV/XLV Evaluator Kit
DENTSPLY INTERNATIONAL INC.
678033
In Commercial Distribution

  • D0026780331 ()

  • Total Volume: 1.6 Milliliter
  • 4 (1.6mL) small cartridges, 2 (2.4mL) large cartridges, 6 mix tips, 6 intraoral tips, 1 syringe dispenser
  • Total Volume: 2.4 Milliliter
678033

  • Silicone dental impression material

Aquasil® Ultra Smart Wetting® Impression Material in digit® Delivery System - D0026780321

Aquasil Ultra digit LV & XLV Fast Set Evaluator Kit
DENTSPLY INTERNATIONAL INC.
678032
Not in Commercial Distribution

  • D0026780321 ()
678032

  • Silicone dental impression material

Aquasil® Ultra Smart Wetting® Impression Material in digit® Delivery System - D0026780311

Aquasil Ultra digit LV & XLV Regular Set Evaluator Kit
DENTSPLY INTERNATIONAL INC.
678031
Not in Commercial Distribution

  • D0026780311 ()
678031

  • Silicone dental impression material

Acu-Flow™ Bite Registration Cartridge - 00359883006631

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016399
In Commercial Distribution

  • 00359883006631 ()

  • Total Volume: 50 Milliliter
1-016399

  • Silicone dental impression material

Acu-Flow™ Rigid Tray Cartridge - 00359883003388

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016409
In Commercial Distribution

  • 00359883003388 ()

  • Total Volume: 50 Milliliter
1-016409

  • Silicone dental impression material

Acu-Flow™ Medium Body Cartridge - 00359883003371

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016408
In Commercial Distribution

  • 00359883003371 ()

  • Total Volume: 50 Milliliter
1-016408

  • Silicone dental impression material

Acu-Flow™ Heavy Body Cartridge - 00359883003364

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016407
In Commercial Distribution

  • 00359883003364 ()

  • Total Volume: 50 Milliliter
1-016407

  • Silicone dental impression material

Acu-Flow™ Light Body Plus Cartridge - 00359883003357

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016406
In Commercial Distribution

  • 00359883003357 ()

  • Total Volume: 50 Milliliter
1-016406

  • Silicone dental impression material

Acu-Flow™ Putty Kit - 00359883003340

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016405
In Commercial Distribution

  • 00359883003340 ()

  • Total Volume: 600 Milliliter
1-016405

  • Silicone dental impression material
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