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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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Self Cure Activator Refill
DENTSPLY INTERNATIONAL INC.
634354
In Commercial Distribution

  • D0026343540 ()

  • Total Volume: 4.5 Milliliter
  • One 4.5mL bottle Self Cure Activator
634354

  • Dentine adhesive
Prime&Bond® NT™ Nano-Technology Dental Adhesive Dual Cure Introductory Kit
DENTSPLY INTERNATIONAL INC.
634353
In Commercial Distribution

  • D0026343531 ()

  • Total Volume: 4.5 Milliliter
  • 1 Bottle Adhesive, 1 Bottle Activator, 1 Syringe Tooth Conditioner Gel, 25 Applicator Tips, 1 Brush Handle, 80 Disposable Brush Tips, 1 Dispensing Well
634353

  • Dentine adhesive
Total Etch Adhesive, 2 (4.5ml) Bottle Refill Package
DENTSPLY INTERNATIONAL INC.
634352
In Commercial Distribution

  • D00263435262 ()
  • D0026343521 ()
  • D0026343520 ()

  • Total Volume: 4.5 Milliliter
  • 2 Bottles Total Etch Adhesive (4.5mL)
634352

  • Dentine adhesive
Prime&Bond® NT™ Total Etch Adhesive Bottle Economy Package
DENTSPLY INTERNATIONAL INC.
634351
In Commercial Distribution

  • D00263435162 ()
  • D0026343511 ()

  • Total Volume: 3 Milliliter
  • 3 Bottles Adhesive, 120 Disposable Brush Tips, 1 Brush Handle, 2 Syringes Tooth Conditioner Gel, 75 Applicator Tips (Needles), 1 Dispensing Well
  • Total Volume: 4.5 Milliliter
634351

  • Dentine adhesive
Prime&Bond® NT™ Nano-Technology Dental Adhesive Introductory Kit
DENTSPLY INTERNATIONAL INC.
634350
In Commercial Distribution

  • D0026343501 ()

  • 1 Bottle P&B Adhesive (4.5mL), 40 Disposable Brush Tips, 1 Brush Handle, 1 Dispensing Well
  • Total Volume: 4.5 Milliliter
634350

  • Dentine adhesive
Prisma® Gloss™ Composite Polishing Paste System Syringe Refill - Extra Fine
DENTSPLY INTERNATIONAL INC.
631450
In Commercial Distribution

  • D00263145042 ()
  • D0026314500 ()

  • 1 Syringe Polishing Paste Extra Fine (4g)
  • Weight: 4 Gram
631450

  • Dental unfilled resin sealant/coating
Prisma® Gloss™ Composite Polishing Paste System Syringe Refill
DENTSPLY INTERNATIONAL INC.
631400
In Commercial Distribution

  • D00263140042 ()
  • D0026314000 ()

  • 1 Syringe Polishing Paste (4g)
  • Weight: 4 Gram
631400

  • Dental unfilled resin sealant/coating
Quixx® Posterior Restorative Evaluator Package
DENTSPLY INTERNATIONAL INC.
631203
In Commercial Distribution

  • D0026312030 ()
  • D0026312031 ()

  • 5 Compules(r) Tips (0.28g each) Universal Shade
631203

  • Dental composite resin
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
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 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 Cups Bulk Package
DENTSPLY INTERNATIONAL INC.
624255
In Commercial Distribution

  • D0026242551 ()
  • D0026242550 ()

  • 1x Jar (1000 cups per jar)
624255

  • 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/Enhance PoGo Polishing System Evaluator Package
DENTSPLY INTERNATIONAL INC.
624205
In Commercial Distribution

  • D0026242051 ()

  • 1x Enhance sample (1 cup/1 disc/1 point), 1x PoGo sample (1 cup/1 disc/1 point)
624205

  • 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
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
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
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