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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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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 (Clear)
DENTSPLY INTERNATIONAL INC.
626382
In Commercial Distribution

  • D0026263820 ()
  • D0026263821 ()

  • 100 Intraoral Tips (Clear)
626382

  • Dental material injection cannula, single-use
Reprosil® Quixx Putty VPS Impression Material (Brown), Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
626230
In Commercial Distribution

  • D00262623082 ()
  • D0026262301 ()
  • D0026262300 ()

  • 4 Cartridges (50mL each), 12 Mixing Tips
  • Total Volume: 50 Milliliter
626230

  • Silicone dental impression material
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 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™ 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
Dycal® Placement Instrument Refill
DENTSPLY INTERNATIONAL INC.
623117
In Commercial Distribution

  • D0026231170 ()
  • D0026231171 ()

  • 12 Dycal Mixing/Placement Instruments
623117

  • Calcium hydroxide dental cement
Tylok® Plus Anhydrous Polycarboxylate Cement, Powder, 1 (50g) bottle Refill
DENTSPLY INTERNATIONAL INC.
620201
In Commercial Distribution

  • D0026202010 ()

  • 1 Powder (50g) 1 Powder Scoop
  • Weight: 50 Gram
620201

  • Zinc polycarboxylate dental cement
Celtra®/Cerec® Block Materials Starter Kit
DENTSPLY INTERNATIONAL INC.
61N010
In Commercial Distribution

  • D00261N0101 ()

  • CEREC® ZIRCONIA/CELTRA® DUO blocks and accessories
  • Total Volume: 15 Milliliter
  • Weight: 4.5 Gram
61N010

  • Dental appliance fabrication material, ceramic
CEREC® Omnicam High Level Disinfection Preventative Care Kit
DENTSPLY INTERNATIONAL INC.
61N003
Not in Commercial Distribution

  • D00261N0031 ()

  • 1 HLD Tank and Cover, 2 plugs, 1 metal bracket, 3 protective caps, 1 container wipes, 1 box masks, 1 bottle Sporox II solution
61N003

  • Medical device disinfection agent
CEREC® Essentials with Zirconia Chairside Consumables Kit
DENTSPLY INTERNATIONAL INC.
61N001
Not in Commercial Distribution

  • D00261N0011 ()

  • 12 CEREC Zirconia blocks, 2 syringes Calibra Universal Cement with 20 mix tips, 1 round dusting brush, 2 Scotch Bright brushes
61N001

  • Dental appliance fabrication material, ceramic
FluoroPost™ Precision Drill Refill - Size 4 (green)
DENTSPLY INTERNATIONAL INC.
61i044
In Commercial Distribution

  • D00261I0440 ()
  • D00261I0441 ()

  • 3 Drills (Size #4 Green)
61i044

  • Fixture/appliance dental drill bit, reusable
FluoroPost™ Precision Drill Refill - Size 2 (red)
DENTSPLY INTERNATIONAL INC.
61i042
In Commercial Distribution

  • D00261I0420 ()
  • D00261I0421 ()

  • 3 Drills (Size #2 Red))
61i042

  • Fixture/appliance dental drill bit, reusable
Algin-X® Ultra Alginate Alternative Sampler
DENTSPLY INTERNATIONAL INC.
61E802
In Commercial Distribution

  • D00261E8021 ()

  • 1 Algin-X® Ultra Cartridge (50mL) and 2 Mixing Tips
  • Total Volume: 50 Milliliter
61E802

  • Silicone dental impression material
Algin-X™ Ultra Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
61E801
In Commercial Distribution

  • D00261E8010 ()
  • D00261E8011 ()
61E801

  • Silicone dental impression material
SDR® Plus Syringe Refill
DENTSPLY INTERNATIONAL INC.
61C130P
In Commercial Distribution

  • D00261C130P0 ()
  • D00261C130P1 ()
61C130P

  • Dental composite resin
SDR® Plus Syringe Tips Refill
DENTSPLY INTERNATIONAL INC.
61C111P
In Commercial Distribution

  • D00261C111P0 ()
  • D00261C111P1 ()

  • 60 Syringe Tips
61C111P

  • Dental material mixing nozzle
SDR® flow+ Syringe Tips Refill
DENTSPLY INTERNATIONAL INC.
61C111G
In Commercial Distribution

  • D00261C111G0 ()
  • D00261C111G1 ()

  • 60 Syringe Tips
61C111G

  • Dental material mixing nozzle
SDR® Plus Compula Refill - Shade A3
DENTSPLY INTERNATIONAL INC.
61C108P
In Commercial Distribution

  • D00261C108P0 ()
  • D00261C108P1 ()
61C108P

  • Dental composite resin
SDR® Plus Compula Refill - Shade A2
DENTSPLY INTERNATIONAL INC.
61C107P
In Commercial Distribution

  • D00261C107P0 ()
  • D00261C107P1 ()
61C107P

  • Dental composite resin
SDR® Plus Compula Refill - Shade A1
DENTSPLY INTERNATIONAL INC.
61C106P
In Commercial Distribution

  • D00261C106P0 ()
  • D00261C106P1 ()
61C106P

  • Dental composite resin
SDR® Plus Bulk Fill Flowable
DENTSPLY INTERNATIONAL INC.
61C104P
In Commercial Distribution

  • D00261C104P1 ()

  • 1 Syringe (1 g), 3 Syringe Tips
61C104P

  • Dental composite resin
SDR® Plus Compula ECO Refill
DENTSPLY INTERNATIONAL INC.
61C103P
In Commercial Distribution

  • D00261C103P0 ()
  • D00261C103P1 ()
61C103P

  • Dental composite resin
SDR® Plus Compula Refill - Shade Universal
DENTSPLY INTERNATIONAL INC.
61C101P
In Commercial Distribution

  • D00261C101P0 ()
  • D00261C101P1 ()
61C101P

  • Dental composite resin
FluoroCore® 2+ Evaluator Kit
DENTSPLY INTERNATIONAL INC.
612406
In Commercial Distribution

  • D0026124061 ()

  • 1 Syringe (tooth colored), 10 Intraoral Tips, 10 Mixing Tips, 10 Endo Intraoral Tips
612406

  • Dental composite resin
Calibra® Abutment Resin Cement Syringe Refill
DENTSPLY INTERNATIONAL INC.
607700
In Commercial Distribution

  • D0026077000 ()

  • 1 Syringe (4.5g), 10 Mix Tips
607700

  • Dental composite resin
Calibra® Veneer Kit
DENTSPLY INTERNATIONAL INC.
607500
In Commercial Distribution

  • D0026075001 ()
607500

  • Dental composite resin
Calibra® Universal+ Sample
DENTSPLY INTERNATIONAL INC.
607410NA
In Commercial Distribution

  • D002607410NA1 ()

  • 2 Syringes (4.5g each); 20 Mixing Tips
607410NA

  • Dental composite resin
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