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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+ Smart Wetting® Impression Material - D0026787041

Aquasil Ultra+ Tray Material Bulk Cartridge Refill, Heavy Extended Set (Green)
DENTSPLY INTERNATIONAL INC.
678704
In Commercial Distribution

  • D0026787040 ()
  • D0026787041 ()
678704

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026787031

Aquasil Ultra+ Tray Material Cartridge Refill, Heavy Extended Set (Green)
DENTSPLY INTERNATIONAL INC.
678703
In Commercial Distribution

  • D0026787030 ()
  • D0026787031 ()
678703

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026787021

Aquasil Ultra+ XLV Extended Set (Orange)
DENTSPLY INTERNATIONAL INC.
678702
Not in Commercial Distribution

  • D0026787020 ()
  • D0026787021 ()
678702

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026787011

Aquasil Ultra+ XLV Extended Set 4-Pack Cartridge Refill (Orange)
DENTSPLY INTERNATIONAL INC.
678701
In Commercial Distribution

  • D0026787010 ()
  • D0026787011 ()
678701

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wedding Impression Material - D0026786990

Aquasil® Ultra+ Regular Set Kit
DENTSPLY INTERNATIONAL INC.
678699
In Commercial Distribution

  • D0026786990 ()

  • 5 Cartridges (50mL), 12 mix tips, 6 I/O tips; 4 small digit (1.6mL) cartridges, 2 large digit (2.4mL) cartridges, 1 syringe dispenser, 6 digit Mix Tips, 6 I/O tips, 1 bottle adhesive (14mL)
678699

  • Silicone dental impression material

Aquasil® Ultra Smart Wetting® Impression Material in digit® Delivery System - D0026786981

Aquasil Ultra+ digit Power XLV FS Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678698
In Commercial Distribution

  • D0026786980 ()
  • D0026786981 ()
678698

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786971

Aquasil® Ultra+ Medium Fast Set DECA 5:1 (2-pack)
DENTSPLY INTERNATIONAL INC.
678697
In Commercial Distribution

  • D0026786973 ()
  • D0026786971 ()
  • D0026786970 ()

  • 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring
  • Total Volume: 380 Milliliter
678697

  • Silicone dental impression material

Aquasil® Ultra+ digit® Smart Wetting® Impression Material - D0026786421

Aquasil® Ultra+ LV Fast Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678642
In Commercial Distribution

  • D0026786421 ()
  • D0026786420 ()

  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 1.6 Milliliter
678642

  • Silicone dental impression material

Aquasil® Ultra+ digit® Smart Wetting® Impression Material - D0026786411

Aquasil® Ultra+ LV Regular Set Large digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678641
In Commercial Distribution

  • D0026786411 ()
  • D0026786410 ()

  • 50 (2.4mL) Large Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 2.4 Milliliter
678641

  • Silicone dental impression material

Aquasil® Ultra+ digit® Smart Wetting® Impression Material - D0026786401

Aquasil® Ultra+ LV Regular Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678640
In Commercial Distribution

  • D0026786401 ()
  • D0026786400 ()

  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 1.6 Milliliter
678640

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786271

Aquasil Ultra+ Rigid Fast Set 50mL Bulk 24 Pack
DENTSPLY INTERNATIONAL INC.
678627
In Commercial Distribution

  • D0026786271 ()
  • D0026786270 ()

  • Total Volume: 50 Milliliter
  • 24 (50mL) cartridges
678627

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786261

Aquasil Ultra+ Heavy Fast Set 50mL Bulk 24 Pack
DENTSPLY INTERNATIONAL INC.
678626
In Commercial Distribution

  • D0026786261 ()
  • D0026786260 ()

  • Total Volume: 50 Milliliter
  • 24 (50mL) cartridges
678626

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786251

Aquasil Ultra+ Heavy Regular Set 50mL Bulk 24 Pack
DENTSPLY INTERNATIONAL INC.
678625
In Commercial Distribution

  • D0026786251 ()
  • D0026786250 ()

  • Total Volume: 50 Milliliter
  • 24 (50mL) cartridges
678625

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786021

Aquasil Ultra+ Medium Regular Set 50mL Bulk 24 Pack
DENTSPLY INTERNATIONAL INC.
678602
In Commercial Distribution

  • D0026786021 ()
  • D0026786020 ()

  • Total Volume: 50 Milliliter
  • 24 (50mL) cartridges
678602

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786011

Aquasil Ultra+ Medium Fast Set 50mL Bulk 24 Pack
DENTSPLY INTERNATIONAL INC.
678601
In Commercial Distribution

  • D0026786011 ()
  • D0026786010 ()

  • Total Volume: 50 Milliliter
  • 24 (50mL) cartridges
678601

  • Silicone dental impression material

Aquasil Ultra LV Fast Set Smart Wetting® Impression Material - D0026784501

Aquasil Ultra LV Fast Set with B4® Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
678450
In Commercial Distribution

  • D00267845082 ()
  • D0026784501 ()
  • D0026784500 ()

  • Total Volume: 50 Milliliter
  • Total Volume: 6 Milliliter
  • 4 cartridges LV FS (50ml), 1 bottle B4 (6ml), 24 Mixing Tips, 24 Intra Oral Tips, 50 Flocked Applicator Tips, 1 Dispensing Well
678450

  • Silicone dental impression material

Aquasil® Ultra Smart Wetting® Impression Material - D0026782761

Aquasil Ultra Heavy FS Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
678276
In Commercial Distribution

  • D0026782760 ()
  • D0026782761 ()
678276

  • Silicone dental impression material

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

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
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