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® 360 Intro Kit with Palodent® V3
DENTSPLY INTERNATIONAL INC.
659600V
In Commercial Distribution

  • D002659600V0 ()

  • 100 Matrices, 75 Wedges, 30 WedgeGuards
659600V

  • Dental matrix band, single-use
Palodent® 360 Intro Kit with Palodent® Plus
DENTSPLY INTERNATIONAL INC.
659600
In Commercial Distribution

  • D0026596000 ()

  • 100 Matrices, 75 Wedges, 30 WedgeGuards
659600

  • Dental matrix band, single-use
Palodent Plus EZ Coat Sectional Matrix System Sample
DENTSPLY INTERNATIONAL INC.
659100
In Commercial Distribution

  • D0026591001 ()

  • 1x Universal Ring, 5x Matrices (size 5.5mm), 5x Medium Wedges, 5x Medium Wedgeguards
659100

  • Dental matrix band, single-use
Palodent Sectional Matrix System Introductory Kit
DENTSPLY INTERNATIONAL INC.
659070Y
In Commercial Distribution

  • D002659070Y1 ()

  • 50x Standard Matrices, 2 BiTine® Round Rings
659070Y

  • Dental matrix band tensioner
  • Dental matrix band, single-use
Palodent Sectional Matrix System Introductory Kit
DENTSPLY INTERNATIONAL INC.
659070
In Commercial Distribution

  • D0026590701 ()

  • 50x Standard Matrices, 2x BiTine® Round Rings
659070

  • Dental matrix band tensioner
  • Dental matrix band, single-use
Palodent Sectional Matrix System Complete Kit
DENTSPLY INTERNATIONAL INC.
659060Y
In Commercial Distribution

  • D002659060Y1 ()

  • 100x Standard Matrices, 50x Mini Matrices, 50x Plus Matrices, 4x BiTine® Round Rings, 2 BiTine® II Oval Rings
659060Y

  • Dental matrix band, single-use
  • Dental matrix band tensioner
Palodent Sectional Matrix System 4 BiTine Round Rings Refill
DENTSPLY INTERNATIONAL INC.
659040
In Commercial Distribution

  • D0026590401 ()
  • D0026590400 ()

  • 4x BiTine® Round Rings
659040

  • Dental matrix band tensioner
Palodent Sectional Matrix System 50 Mini Matrices Refill
DENTSPLY INTERNATIONAL INC.
659020
In Commercial Distribution

  • D0026590201 ()
  • D0026590200 ()

  • 50x Mini Matrices
659020

  • Dental matrix band, single-use
Palodent Sectional Matrix System 50 Standard Matrices Refill
DENTSPLY INTERNATIONAL INC.
659015
In Commercial Distribution

  • D0026590151 ()
  • D0026590150 ()

  • 50x Standard Matrices
659015

  • Dental matrix band, single-use
Esthet-X® HD Compule Sampler - Shade A2
DENTSPLY INTERNATIONAL INC.
630606
Not in Commercial Distribution

  • D0026306060 ()
  • D0026306061 ()

  • 3 Compules® Tips - Shade A2
630606

  • Dental composite resin
Esthet-X® HD Compule Sampler
DENTSPLY INTERNATIONAL INC.
630602
Not in Commercial Distribution

  • D0026306020 ()

  • 8 Compules® Tips, 1 Shade Tab (A2)
630602

  • Dental composite resin
Dentsply Sirona Intraoral Tip Sample Package
DENTSPLY INTERNATIONAL INC.
626392
Not in Commercial Distribution

  • D0026263920 ()
  • D0026263921 ()

  • 6 Intraoral Tips
626392

  • Dental material injection cannula, single-use
Dentsply Sirona Intraoral Tip Refill (Red)
DENTSPLY INTERNATIONAL INC.
626383
In Commercial Distribution

  • D0026263830 ()
  • D0026263831 ()

  • 100 Red Intraoral Tips
626383

  • Dental material injection cannula, single-use
Dentsply Sirona Intraoral Tip Refill (Clear)
DENTSPLY INTERNATIONAL INC.
626382
In Commercial Distribution

  • D0026263820 ()
  • D0026263821 ()

  • 100 Intraoral Tips (Clear)
626382

  • Dental material injection cannula, single-use
Polytray Handles
DENTSPLY INTERNATIONAL INC.
62455105
In Commercial Distribution

  • D002624551050 ()
  • D002624551051 ()
62455105

  • Dental impression tray, single-use
Polytray Assorted Color
DENTSPLY INTERNATIONAL INC.
62455103
In Commercial Distribution

  • D002624551030 ()
  • D002624551031 ()
62455103

  • Dental impression tray, single-use
Polytray Upper 2 Yellow
DENTSPLY INTERNATIONAL INC.
62455102
In Commercial Distribution

  • D002624551020 ()
  • D002624551021 ()
62455102

  • Dental impression tray, single-use
Polytray Upper 1 Blue
DENTSPLY INTERNATIONAL INC.
62455101
In Commercial Distribution

  • D002624551010 ()
  • D002624551011 ()
62455101

  • Dental impression tray, single-use
Polytray Upper 0 Green
DENTSPLY INTERNATIONAL INC.
62455100
In Commercial Distribution

  • D002624551000 ()
  • D002624551001 ()
62455100

  • Dental impression tray, single-use
Polytray Lower 2 Yellow
DENTSPLY INTERNATIONAL INC.
62455002
In Commercial Distribution

  • D002624550020 ()
  • D002624550021 ()
62455002

  • Dental impression tray, single-use
Polytray Lower 1 Blue
DENTSPLY INTERNATIONAL INC.
62455001
In Commercial Distribution

  • D002624550010 ()
  • D002624550011 ()
62455001

  • Dental impression tray, single-use
Polytray Lower 0 Green
DENTSPLY INTERNATIONAL INC.
62455000
In Commercial Distribution

  • D002624550000 ()
  • D002624550001 ()
62455000

  • Dental impression tray, single-use
Enhance Finishing System Finishing Points Bulk Package
DENTSPLY INTERNATIONAL INC.
624265
In Commercial Distribution

  • D0026242651 ()
  • D0026242650 ()

  • 1x jar (1000 points per jar)
624265

  • Dental abrasive disk, reusable
Enhance Finishing System Finishing Discs Bulk Package
DENTSPLY INTERNATIONAL INC.
624245
In Commercial Distribution

  • D0026242451 ()
  • D0026242450 ()

  • 1x jar (1000 discs per jar)
624245

  • Dental abrasive disk, reusable
Enhance® Finishing System COMPLETE System Kit
DENTSPLY INTERNATIONAL INC.
624075
In Commercial Distribution

  • D0026240751 ()

  • 20 Finishing discs, 10 Finishing Points, 10 Finishing Cups, 25 Polishing Cups, 1 Metal Mandrel, 1 Prisma Gloss Composite Polishing Paste, 1 Prisma Gloss Extrafine Composite Polishing Paste
624075

  • Dental abrasive disk, reusable
Enhance Finishing System Point Refill Package - Export Only
DENTSPLY INTERNATIONAL INC.
624065X
In Commercial Distribution

  • D002624065X1 ()
  • D002624065X0 ()

  • 30x finishing points
624065X

  • Dental abrasive disk, reusable
Enhance® Finishing System POINT Refill Package, 40 Points
DENTSPLY INTERNATIONAL INC.
624065
In Commercial Distribution

  • D0026240651 ()
  • D0026240650 ()

  • 40 Finishing Points
624065

  • Dental abrasive disk, reusable
Enhance Finishing System Cup Refill Package - Export Only
DENTSPLY INTERNATIONAL INC.
624055X
In Commercial Distribution

  • D002624055X1 ()
  • D002624055X0 ()

  • 30x finishing cups
624055X

  • Dental abrasive disk, reusable
Enhance® Finishing System CUP Refill Package, 40 Cups
DENTSPLY INTERNATIONAL INC.
624055
In Commercial Distribution

  • D0026240551 ()
  • D0026240550 ()

  • 40 Finishing Cups
624055

  • Dental abrasive disk, reusable
Enhance Finishing System Disc Refill Package - Export Only
DENTSPLY INTERNATIONAL INC.
624045X
In Commercial Distribution

  • D002624045X1 ()
  • D002624045X0 ()

  • 30x finishing discs
624045X

  • Dental abrasive disk, reusable
Enhance® Finishing System DISC Refill Package, 40 Discs
DENTSPLY INTERNATIONAL INC.
624045
In Commercial Distribution

  • D0026240451 ()
  • D0026240450 ()

  • 40 Finishing Discs
624045

  • Dental abrasive disk, reusable
Enhance Finishing System Sample
DENTSPLY INTERNATIONAL INC.
624040
In Commercial Distribution

  • D0026240401 ()

  • 1x finishing point, 1x finishing cup, 1x finishing disc
624040

  • Dental abrasive disk, reusable
Metal Mandrel for Prisma® Gloss™ Polishing Cups, 3 Metal Mandrels
DENTSPLY INTERNATIONAL INC.
624025
In Commercial Distribution

  • D0026240250 ()
  • D0026240251 ()

  • 3 Metal Mandrels
624025

  • Dental mandrel
Prisma® Gloss™ Polishing Cups Refill
DENTSPLY INTERNATIONAL INC.
624020
In Commercial Distribution

  • D0026240201 ()
  • D0026240200 ()

  • 100 Polishing Cups, 1 Mandrel
624020

  • Dental unfilled resin sealant/coating
  • Dental mandrel
Prisma® Gloss™ Composite Polishing Paste System Refill Package
DENTSPLY INTERNATIONAL INC.
624005
In Commercial Distribution

  • D0026240051 ()

  • Weight: 4 Gram
  • 1 Syringe Composite Polishing Paste (4g), 1 Syringe Extrafine Composite Polishing Paste (4g), 25 Polishing Cups, 1 Metal Mandrel
624005

  • Dental unfilled resin sealant/coating
Tylok® Plus Anhydrous Polycarboxylate Cement Standard Package
DENTSPLY INTERNATIONAL INC.
620200
In Commercial Distribution

  • D0026202001 ()

  • Weight: 50 Gram
  • 1 Powder (50g), 1 Water Dispenser Bottle, 1 Mixing Pad, Accessories
620200

  • Zinc polycarboxylate dental cement
SDR® Plus Syringe Tips Refill
DENTSPLY INTERNATIONAL INC.
61C111P
In Commercial Distribution

  • D00261C111P0 ()
  • D00261C111P1 ()

  • 60 Syringe Tips
61C111P

  • Dental material mixing nozzle
SDR® Plus Compula Refill - Shade A2
DENTSPLY INTERNATIONAL INC.
61C107P
In Commercial Distribution

  • D00261C107P0 ()
  • D00261C107P1 ()
61C107P

  • Dental composite resin
Aquasil Ultra+ XLV FS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678714
In Commercial Distribution

  • D0026787140 ()
  • D0026787141 ()
678714

  • Silicone dental impression material
Aquasil Ultra+ LV FS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678713
In Commercial Distribution

  • D0026787130 ()
  • D0026787131 ()
678713

  • Silicone dental impression material
Aquasil Ultra+ XLV RS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678707
In Commercial Distribution

  • D0026787070 ()
  • D0026787071 ()
678707

  • Silicone dental impression material
Aquasil Ultra+ LV RS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678706
In Commercial Distribution

  • D0026787060 ()
  • D0026787061 ()
678706

  • Silicone dental impression material
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+ Introductory Kit
DENTSPLY INTERNATIONAL INC.
678695
In Commercial Distribution

  • D0026786951 ()

  • 2 AU+ Heavy FS 50mL cartridges, 1 AU+ LV FS 50mL cartridge, 1 AU+ XLV FS 50mL cartridge, 12 mix tips, 6 intraoral tips, 1 bottle (14mL) Caulk tray adhesive, 1 AU+ digit LV/XLV FS evaulator kit
  • Total Volume: 50 Milliliter
678695

  • Silicone dental impression material
Aquasil Ultra+ digit Power LV FS Small Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678694
In Commercial Distribution

  • D0026786940 ()
  • D0026786941 ()
678694

  • 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 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+ 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 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+ 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
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