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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 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

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

SmartCem®2 Self-Adhesive Cement - D0026690151

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 - D0026690131

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

Integrity® Temporary Crown & Bridge Material mini-SYRINGE - D0026663500

Integrity® Temporary Crown and Bridge Material, A1, mini-SYRINGE Refill
DENTSPLY INTERNATIONAL INC.
666350
In Commercial Distribution

  • D0026663500 ()

  • Weight: 15 Gram
  • 1 mini-Syringe (15g), 10 mini-Syringe Mixing Tips
666350

  • Temporary dental crown/bridge

Integrity® Temporary Crown & Bridge Material mini-SYRINGE - D0026663450

Integrity® Temporary Crown and Bridge Material, Bleach White, mini-SYRINGE Refill
DENTSPLY INTERNATIONAL INC.
666345
In Commercial Distribution

  • D0026663450 ()

  • 1 mini-Syringe (15g), 10 mini-Syringe Mixing Tips
  • Weight: 15 Gram
666345

  • Temporary dental crown/bridge

Integrity® Temporary Crown & Bridge Material mini-SYRINGE - D0026663400

Integrity® Temporary Crown and Bridge Material, B1, mini-SYRINGE Refill
DENTSPLY INTERNATIONAL INC.
666340
In Commercial Distribution

  • D0026663400 ()

  • 1 mini-Syringe (15g), 10 mini-Syringe Mixing Tips
  • Weight: 15 Gram
666340

  • Temporary dental crown/bridge

Integrity® Temporary Crown & Bridge Material mini-SYRINGE - D0026663300

Integrity® Temporary Crown and Bridge Material, A3.5, mini-SYRINGE Refill
DENTSPLY INTERNATIONAL INC.
666330
In Commercial Distribution

  • D0026663300 ()

  • Weight: 15 Gram
  • 1 mini-Syringe (15g), 10 mini-Syringe Mixing Tips
666330

  • Temporary dental crown/bridge

Integrity® Temporary Crown & Bridge Material mini-SYRINGE - D0026663200

Integrity® Temporary Crown and Bridge Material, A2, mini-SYRINGE Refill
DENTSPLY INTERNATIONAL INC.
666320
In Commercial Distribution

  • D0026663200 ()

  • 1 mini-Syringe (15g), 10 mini-Syringe Mixing Tips
  • Weight: 15 Gram
666320

  • Temporary dental crown/bridge

Palodent® V3 Sectional Matrix System Designed by Triodent® - D002662024V1

Palodent V3 Small WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659830V
In Commercial Distribution

  • D002662024V1 ()
  • D002662024V0 ()

  • 50x WedgeGuards (Small)
659830V

  • Dental wedge, single-use

Palodent® Plus Sectional Matrix System - D0026599001

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 Sectional Matrix System - D0026598901

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 Sectional Matrix System - D0026598801

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 Sectional Matrix System Designed by Triodent® - D002659860V1

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 - D0026598601

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

Palodent® Plus Sectional Matrix System - D0026598501

Palodent Plus Large WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659850
In Commercial Distribution

  • D0026598501 ()
  • D0026598500 ()

  • 50x WedgeGuards (Large)
659850

  • Dental wedge, single-use

Palodent® V3 Sectional Matrix System Designed by Triodent® - D002659840V1

Palodent V3 Medium WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659840V
In Commercial Distribution

  • D002659840V1 ()
  • D002659840V0 ()

  • 50x WedgeGuards (Medium)
659840V

  • Dental wedge, single-use

Palodent® Plus Sectional Matrix System - D0026598401

Palodent Plus Medium WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659840
In Commercial Distribution

  • D0026598401 ()
  • D0026598400 ()

  • 50x WedgeGuards (Medium)
659840

  • Dental wedge, single-use

Palodent® Plus Sectional Matrix System - D0026598301

Palodent Plus Small WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659830
In Commercial Distribution

  • D0026598301 ()
  • D0026598300 ()

  • 50x WedgeGuards (Small)
659830

  • Dental wedge, single-use

Palodent® V3 Sectional Matrix System Designed by Triodent® - D002659820V1

Palodent V3 Pin Tweezers Refill
DENTSPLY INTERNATIONAL INC.
659820V
In Commercial Distribution

  • D002659820V1 ()

  • 1x Pin Tweezers
659820V

  • Rubber dam clamp forceps
  • Dental dressing forceps, reusable

Palodent® Plus Sectional Matrix System - D0026598201

Palodent Plus Pin Tweezers Refill
DENTSPLY INTERNATIONAL INC.
659820
In Commercial Distribution

  • D0026598201 ()

  • 1x Pin Tweezers
659820

  • Dental dressing forceps, reusable
  • Rubber dam clamp forceps

Palodent® V3 Sectional Matrix System Designed by Triodent® - D002659810V1

Palodent V3 Forceps Refill
DENTSPLY INTERNATIONAL INC.
659810V
In Commercial Distribution

  • D002659810V1 ()

  • 1x Forceps
659810V

  • Rubber dam clamp forceps
  • Dental dressing forceps, reusable

Palodent® Plus Sectional Matrix System - D0026598101

Palodent Plus Forceps Refill
DENTSPLY INTERNATIONAL INC.
659810
In Commercial Distribution

  • D0026598101 ()

  • 1x Forceps
659810

  • Dental dressing forceps, reusable
  • Rubber dam clamp forceps
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