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

  • D0026780321 ()
678032

  • Silicone dental impression material
Aquasil Ultra digit LV & XLV Regular Set Evaluator Kit
DENTSPLY INTERNATIONAL INC.
678031
Not in Commercial Distribution

  • D0026780311 ()
678031

  • Silicone dental impression material
SmartCem®2 Self-Adhesive Cement Syringe Refill, Opaque
DENTSPLY INTERNATIONAL INC.
669016
In Commercial Distribution

  • D0026690161 ()
  • D0026690160 ()

  • Weight: 5 Gram
  • 2 Syringes (5g each)-Opaque, 20 Mixing Tips
669016

  • Dental composite resin
SmartCem®2 Self-Adhesive Cement Syringe Refill, Translucent
DENTSPLY INTERNATIONAL INC.
669015
In Commercial Distribution

  • D0026690151 ()
  • D0026690150 ()

  • 2 Syringes (5g each)-Translucent, 20 Mixing Tips
  • Weight: 5 Gram
669015

  • Dental composite resin
SmartCem®2 Self-Adhesive Cement Syringe Refill, Dark
DENTSPLY INTERNATIONAL INC.
669014
In Commercial Distribution

  • D0026690141 ()
  • D0026690140 ()

  • Weight: 5 Gram
  • 2 Syringes (5g each)-Dark, 20 Mixing Tips
669014

  • Dental composite resin
SmartCem®2 Self-Adhesive Cement Syringe Refill, Medium
DENTSPLY INTERNATIONAL INC.
669013
In Commercial Distribution

  • D0026690131 ()
  • D0026690130 ()

  • Weight: 5 Gram
  • 2 Syringes (5g each)-Medium, 20 Mixing Tips
669013

  • Dental composite resin
SmartCem®2 Self-Adhesive Cement Syringe Refill, Light
DENTSPLY INTERNATIONAL INC.
669012
In Commercial Distribution

  • D0026690121 ()
  • D0026690120 ()

  • Weight: 5 Gram
  • 2 Syringes (5g each)-Light, 20 Mixing Tips
669012

  • Dental composite resin
Palodent V3 Small WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659830V
In Commercial Distribution

  • D002662024V1 ()
  • D002662024V0 ()

  • 50x WedgeGuards (Small)
659830V

  • Dental wedge, single-use
Enhance PoGo Polishing System Cup Refill
DENTSPLY INTERNATIONAL INC.
662023
In Commercial Distribution

  • D0026620231 ()
  • D0026620230 ()

  • 40x polishing cups
662023

  • Dental abrasive disk, reusable
Palodent V3 Large WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659850V
In Commercial Distribution

  • D002662022V1 ()
  • D002662022V0 ()

  • 50x WedgeGuards (Large)
659850V

  • Dental wedge, single-use
Enhance® PoGo® COMPLETE Kit
DENTSPLY INTERNATIONAL INC.
662020
In Commercial Distribution

  • D0026620201 ()

  • Ehance Finishers- 10 each of discs, cups, and points; PoGo Polishers - 10 each of discs, cups, and points
662020

  • Dental abrasive disk, reusable
Palodent V3 Universal Rings Refill
DENTSPLY INTERNATIONAL INC.
659900V
In Commercial Distribution

  • D002659900V1 ()

  • 1x Universal Ring
659900V

  • Dental matrix band tensioner
Palodent Plus Sectional Matrix System Ring Refill
DENTSPLY INTERNATIONAL INC.
659900
In Commercial Distribution

  • D0026599001 ()

  • 1x Universal Ring
659900

  • Dental matrix band tensioner
Palodent Plus Sample
DENTSPLY INTERNATIONAL INC.
659890
In Commercial Distribution

  • D0026598901 ()

  • 1x Universal Ring, 5x Matrices (size 5.5mm), 5x Medium Wedges, 5x Medium Wedgeguards
659890

  • Dental matrix band tensioner
  • Dental matrix band, single-use
  • Dental wedge, single-use
Palodent Plus Trial Kit
DENTSPLY INTERNATIONAL INC.
659880
In Commercial Distribution

  • D0026598801 ()

  • 1x Universal Ring, 10x Matrices (5.5mm), 10x Medium Wedges, 10x Medium WedgeGuards, 5x SureFil® SDR® Compula® Tips (Universal shade), 1x Forceps, 1x Pin Tweezers
659880

  • Dental matrix band, single-use
  • Dental wedge, single-use
  • Rubber dam clamp forceps
  • Dental matrix band tensioner
  • Dental dressing forceps, reusable
Palodent V3 7.5mm Matrix Bands Refill
DENTSPLY INTERNATIONAL INC.
659860V
In Commercial Distribution

  • D002659860V1 ()
  • D002659860V0 ()

  • 50x Bands (7.5mm)
659860V

  • Dental matrix band, single-use
Palodent V3 Sectional Matrix System 7.5mm Matrix Bands Refill
DENTSPLY INTERNATIONAL INC.
659860
In Commercial Distribution

  • D0026598601 ()
  • D0026598600 ()

  • 50x Bands (7.5mm)
659860

  • Dental matrix band, single-use
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