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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 - 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

Aquasil® Ultra Smart Wetting® Impression Material - D0026782751

Aquasil Ultra Heavy RS Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
678275
In Commercial Distribution

  • D0026782750 ()
  • D0026782751 ()
678275

  • Silicone dental impression material

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

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 - D0026690161

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 - 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 - D0026690141

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 - 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

SmartCem®2 Self-Adhesive Cement - D0026690121

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

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

AutoMatrix® Retainerless Matrix System - D0026630321

AutoMatrix Retainerless Matrix System Introductory Kit
DENTSPLY INTERNATIONAL INC.
663032
In Commercial Distribution

  • D0026630321 ()

  • 96x bands (24 each size) , 1x tightening device, 1x Snippers, 6x catch trays
663032

  • Dental matrix band, single-use

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

Enhance® PoGo® Polishing System - D0026620231

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 Sectional Matrix System Designed by Triodent® - D002662022V1

Palodent V3 Large WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659850V
In Commercial Distribution

  • D002662022V1 ()
  • D002662022V0 ()

  • 50x WedgeGuards (Large)
659850V

  • Dental wedge, single-use

Enhance® PoGo® Polishing System - D0026620201

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 Sectional Matrix System Designed by Triodent® - D002659900V1

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 - 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

Palodent® V3 Sectional Matrix System Designed by Triodent® - D002659800V1

Palodent V3 Large Wedges Refill
DENTSPLY INTERNATIONAL INC.
659800V
In Commercial Distribution

  • D002659800V1 ()
  • D002659800V0 ()

  • 100x Wedges (Large)
659800V

  • Dental wedge, single-use

Palodent® Plus Sectional Matrix System - D0026598001

Palodent Plus Large Wedges Refill
DENTSPLY INTERNATIONAL INC.
659800
In Commercial Distribution

  • D0026598001 ()
  • D0026598000 ()

  • 100x Wedges (Large)
659800

  • Dental wedge, single-use

Palodent® V3 Sectional Matrix System Designed by Triodent® - D002659790V1

Palodent V3 Medium Wedges Refill
DENTSPLY INTERNATIONAL INC.
659790V
In Commercial Distribution

  • D002659790V1 ()
  • D002659790V0 ()

  • 100x Wedges (Medium)
659790V

  • Dental wedge, single-use

Palodent® Plus Sectional Matrix System - D0026597901

Palodent Plus Medium Wedges Refill
DENTSPLY INTERNATIONAL INC.
659790
In Commercial Distribution

  • D0026597901 ()
  • D0026597900 ()

  • 100x Wedges (Medium)
659790

  • Dental wedge, single-use

Palodent® V3 Sectional Matrix System Designed by Triodent® - D002659780V1

Palodent V3 Small Wedges Refill
DENTSPLY INTERNATIONAL INC.
659780V
In Commercial Distribution

  • D002659780V1 ()
  • D002659780V0 ()

  • 100x Wedges (Small)
659780V

  • Dental wedge, single-use

Palodent® Plus Sectional Matrix System - D0026597801

Palodent Plus Small Wedges Refill
DENTSPLY INTERNATIONAL INC.
659780
In Commercial Distribution

  • D0026597801 ()
  • D0026597800 ()

  • 100x Wedges (Small)
659780

  • Dental wedge, single-use

Palodent® V3 Sectional Matrix System Designed by Triodent® - D002659770V1

Palodent V3 Narrow Rings Refill
DENTSPLY INTERNATIONAL INC.
659770V
In Commercial Distribution

  • D002659770V1 ()
  • D002659770V0 ()

  • 2x Narrow Rings
659770V

  • Dental matrix band tensioner

Palodent® Plus Sectional Matrix System - D0026597701

Palodent Plus Narrow Ring Refill
DENTSPLY INTERNATIONAL INC.
659770
In Commercial Distribution

  • D0026597701 ()
  • D0026597700 ()

  • 2x Narrow Rings
659770

  • Dental matrix band tensioner
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