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+ Medium Regular Set DECA 5:1 (2-pack)
DENTSPLY INTERNATIONAL INC.
678682
In Commercial Distribution

  • D00267868232 ()
  • D0026786821 ()
  • D0026786820 ()

  • Total Volume: 380 Milliliter
  • 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring
678682

  • Silicone dental impression material
Aquasil® Ultra+ Rigid Fast Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678678
In Commercial Distribution

  • D00267867882 ()
  • D0026786781 ()
  • D0026786780 ()

  • Total Volume: 50 Milliliter
  • 32 (50mL) cartridges, 12 mixing tips
678678

  • Silicone dental impression material
Aquasil® Ultra+ Heavy Fast Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678676
In Commercial Distribution

  • D00267867682 ()
  • D0026786761 ()
  • D0026786760 ()

  • 32 (50mL) cartridges, 12 mixing tips
  • Total Volume: 50 Milliliter
678676

  • Silicone dental impression material
Aquasil® Ultra+ Medium Fast Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678674
In Commercial Distribution

  • D00267867482 ()
  • D0026786741 ()
  • D0026786740 ()

  • Total Volume: 50 Milliliter
  • 32 (50mL) cartridges, 12 mixing tips
678674

  • Silicone dental impression material
Aquasil® Ultra+ Medium Regular Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678673
In Commercial Distribution

  • D00267867382 ()
  • D0026786731 ()
  • D0026786730 ()

  • Total Volume: 50 Milliliter
  • 32 (50mL) cartridges, 12 mixing tips
678673

  • Silicone dental impression material
Aquasil® Ultra+ LV Fast Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678672
In Commercial Distribution

  • D00267867282 ()
  • D0026786721 ()
  • D0026786720 ()

  • 32 (50mL) cartridges, 12 mixing tips, 12 intraoral tips
  • Total Volume: 50 Milliliter
678672

  • Silicone dental impression material
Aquasil® Ultra+ LV Regular Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678671
In Commercial Distribution

  • D00267867182 ()
  • D0026786711 ()
  • D0026786710 ()

  • Total Volume: 50 Milliliter
  • 32 (50mL) cartridges, 12 mixing tips, 12 intraoral tips
678671

  • Silicone dental impression material
Aquasil® Ultra+ Starter Kit
DENTSPLY INTERNATIONAL INC.
678649
In Commercial Distribution

  • D0026786491 ()
678649

  • Silicone dental impression material
Aquasil Ultra+ DECA Heavy/XLV Extended Set Kit
DENTSPLY INTERNATIONAL INC.
678648
Not in Commercial Distribution

  • D0026786481 ()
678648

  • Silicone dental impression material
Aquasil® Ultra+ XLV Fast Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678645
In Commercial Distribution

  • D0026786451 ()
  • D0026786450 ()

  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 1.6 Milliliter
678645

  • Silicone dental impression material
Aquasil® Ultra+ XLV Regular Set Large digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678644
In Commercial Distribution

  • D0026786441 ()
  • D0026786440 ()

  • Total Volume: 2.4 Milliliter
  • 50 (2.4mL) Large Unit Doses, 50 Mix Tips, 50 Intraoral Tips
678644

  • Silicone dental impression material
Aquasil® Ultra+ XLV Regular Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678643
In Commercial Distribution

  • D0026786431 ()
  • D0026786430 ()

  • Total Volume: 1.6 Milliliter
  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
678643

  • Silicone dental impression material
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+ 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+ 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+ 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+ 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+ 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+ 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+ 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 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 Heavy FS Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
678276
In Commercial Distribution

  • D0026782760 ()
  • D0026782761 ()
678276

  • Silicone dental impression material
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 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 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 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 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 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 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
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 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 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 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 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 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 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
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