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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Palodent V3 4.5mm Matrix Bands Refill
DENTSPLY INTERNATIONAL INC.
659720V
In Commercial Distribution

  • D002659720V1 ()
  • D002659720V0 ()

  • 50x Bands (4.5mm)
659720V

  • Dental matrix band, single-use
Palodent V3 Sectional Matrix System 4.5mm Matrix Bands Refill
DENTSPLY INTERNATIONAL INC.
659720
In Commercial Distribution

  • D0026597201 ()
  • D0026597200 ()

  • 50x Bands (4.5mm)
659720

  • Dental matrix band, single-use
Palodent V3 3.5mm Matrix Bands Refill
DENTSPLY INTERNATIONAL INC.
659710V
In Commercial Distribution

  • D002659710V1 ()
  • D002659710V0 ()

  • 50x Bands (3.5mm)
659710V

  • Dental matrix band, single-use
Palodent V3 Sectional Matrix System 3.5mm Matrix Bands Refill
DENTSPLY INTERNATIONAL INC.
659710
In Commercial Distribution

  • D0026597101 ()
  • D0026597100 ()

  • 50x Bands (3.5mm)
659710

  • Dental matrix band, single-use
Palodent Plus Introductory Kit
DENTSPLY INTERNATIONAL INC.
659700
In Commercial Distribution

  • D0026597001 ()

  • 1x Universal Ring, 1x Narrow Ring, 25x Matrices each of 4 sizes, 25x Wedges each of 3 sizes, 10x WedgeGuards each of 3 sizes, 1x Forceps, 1x Pin Tweezers
659700

  • Dental matrix band tensioner
  • Dental dressing forceps, reusable
  • Dental matrix band, single-use
  • Rubber dam clamp forceps
  • Dental wedge, single-use
Palodent V3 EZ Coat Introductory Kit
DENTSPLY INTERNATIONAL INC.
659670V
In Commercial Distribution

  • D002659670V1 ()

  • 1x Universal Ring, 1x Narrow Ring, 20x Matrices each of 5 sizes, 25x Wedges each of 3 sizes, 10x WedgeGuards each of 3 sizes, 1x Forceps, 1x Pin Tweezers
659670V

  • Dental matrix band, single-use
Palodent Plus EZ Coat Introductory Kit
DENTSPLY INTERNATIONAL INC.
659670
In Commercial Distribution

  • D0026596701 ()

  • 20x each of matrix bands (5 sizes), 25x each of wedges (3 sizes), 10x each of wedge guards (3 sizes), 2x Rings, 1x Forceps, 1x Tweezers
659670

  • Dental matrix band, single-use
Palodent V3 EZ Coat 7.5mm Matrices Refill
DENTSPLY INTERNATIONAL INC.
659660V
In Commercial Distribution

  • D002659660V1 ()
  • D002659660V0 ()

  • 50x Matrices (7.5mm)
659660V

  • Dental matrix band, single-use
Palodent Plus EZ Coat 7.5mm Matrices Refill
DENTSPLY INTERNATIONAL INC.
659660
In Commercial Distribution

  • D0026596601 ()
  • D0026596600 ()

  • 50x Matrices (7.5mm)
659660

  • Dental matrix band, single-use
Palodent Plus EZ Coat 6.5mm Matrices Refill
DENTSPLY INTERNATIONAL INC.
659650
In Commercial Distribution

  • D0026596501 ()
  • D0026596500 ()

  • 50x Matrices (6.5mm)
659650

  • Dental matrix band, single-use
Palodent V3 EZ Coat 5.5mm Matrices Refill (90)
DENTSPLY INTERNATIONAL INC.
659640V
In Commercial Distribution

  • D002659640V1 ()
  • D002659640V0 ()

  • 90x Matrices (5.5mm)
659640V

  • Dental matrix band, single-use
Palodent Plus EZ Coat 5.5mm Matrices Refill (90)
DENTSPLY INTERNATIONAL INC.
659640
In Commercial Distribution

  • D0026596401 ()
  • D0026596400 ()

  • 90x Matrices (5.5mm)
659640

  • Dental matrix band, single-use
Lynal® Tissue Conditioner & Temporary Reliner Package
DENTSPLY INTERNATIONAL INC.
653006
In Commercial Distribution

  • D0026530060 ()

  • Total Volume: 90 Milliliter
  • Weight: 120 Gram
  • 1 Powder (120g), 1 Liquid (90 mL), 1 Separator (15mL), and Accessories
653006

  • Denture reliner, soft, professional
Caulk® 34% Tooth Conditioner Gel Syringe Refill
DENTSPLY INTERNATIONAL INC.
646125
In Commercial Distribution

  • D00264612562 ()
  • D0026461251 ()
  • D0026461250 ()

  • Total Volume: 3 Milliliter
  • 2 Syringes Caulk® Tooth Conditioner Gel (3mL each) and 25 Applicator Tips
646125

  • Dental etching solution
Comspan Composite Luting Cement Opaque Catalyst
DENTSPLY INTERNATIONAL INC.
955251
In Commercial Distribution

  • D0029552511 ()

  • 1x jar Catalyst (5g)
  • Weight: 5 Gram
955251

  • Dental composite resin
Comspan Composite Luting Cement Opaque Base
DENTSPLY INTERNATIONAL INC.
955250
In Commercial Distribution

  • D0029552501 ()

  • 1x jar Base (5g)
  • Weight: 5 Gram
955250

  • Dental composite resin
Prime&Bond® XP Etch&Rinse Adhesive Unit Dose Package
DENTSPLY INTERNATIONAL INC.
693002
In Commercial Distribution

  • D0026930020 ()
  • D0026930021 ()
693002

  • Dentine bonding agent/set
Aquasil® Ultra+ Heavy Regular Set DECA 5:1 (2-pack)
DENTSPLY INTERNATIONAL INC.
678686
In Commercial Distribution

  • D00267868632 ()
  • D0026786861 ()
  • D0026786860 ()

  • 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring
  • Total Volume: 380 Milliliter
678686

  • Silicone dental impression material
Aquasil® Ultra+ Heavy Fast Set DECA 5:1 (2-pack)
DENTSPLY INTERNATIONAL INC.
678684
In Commercial Distribution

  • D00267868432 ()
  • D0026786841 ()
  • D0026786840 ()

  • Total Volume: 380 Milliliter
  • 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring
678684

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

  • D0026782760 ()
  • D0026782761 ()
678276

  • 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
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, 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, 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
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
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 V3 EZ Coat 6.5mm Matrices Refill
DENTSPLY INTERNATIONAL INC.
659650V
In Commercial Distribution

  • D002659650V1 ()
  • D002659650V0 ()

  • 50x Matrices (6.5mm)
659650V

  • Dental matrix band, single-use
Palodent V3 EZ Coat 5.5mm Matrices Refill
DENTSPLY INTERNATIONAL INC.
659630V
In Commercial Distribution

  • D002659630V1 ()
  • D002659630V0 ()

  • 50x Matrices (5.5mm)
659630V

  • Dental matrix band, single-use
Palodent Plus EZ Coat 5.5mm Matrices Refill
DENTSPLY INTERNATIONAL INC.
659630
In Commercial Distribution

  • D0026596301 ()
  • D0026596300 ()

  • 50x Matrices (5.5mm)
659630

  • Dental matrix band, single-use
Palodent V3 EZ Coat 4.5mm Matrices Refill
DENTSPLY INTERNATIONAL INC.
659620V
In Commercial Distribution

  • D002659620V1 ()
  • D002659620V0 ()

  • 50x Matrices (4.5mm)
659620V

  • Dental matrix band, single-use
Palodent Plus EZ Coat 4.5mm Matrices Refill
DENTSPLY INTERNATIONAL INC.
659620
In Commercial Distribution

  • D0026596201 ()
  • D0026596200 ()

  • 50x Matrices (4.5mm)
659620

  • Dental matrix band, single-use
Palodent V3 EZ Coat 3.5 mm Matrices Refill
DENTSPLY INTERNATIONAL INC.
659610V
In Commercial Distribution

  • D002659610V1 ()
  • D002659610V0 ()

  • 50x Matrices (3.5mm)
659610V

  • Dental matrix band, single-use
Palodent Plus EZ Coat 3.5mm Matrices Refill
DENTSPLY INTERNATIONAL INC.
659610
In Commercial Distribution

  • D0026596101 ()
  • D0026596100 ()

  • 50x Matrices (3.5mm)
659610

  • Dental matrix band, single-use
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