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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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Calibra® Esthetic Resin Cement, Catalyst, Regular Viscosity, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607068
In Commercial Distribution

  • D0026070680 ()

  • 1 Syringe Calibra® Catalyst (2g), Regular Viscosity
  • Weight: 2 Gram
607068

  • Dental composite resin
Calibra® Esthetic Resin Cement, Base, Opaque, 1 (2g) syringe Refill Page
DENTSPLY INTERNATIONAL INC.
607065
In Commercial Distribution

  • D0026070650 ()

  • Weight: 2 Gram
  • 1 Syringe Calibra® Base Shade (2g), Opaque
607065

  • Dental composite resin
Calibra® Esthetic Resin Cement, Base, Translucent, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607064
In Commercial Distribution

  • D0026070640 ()

  • 1 Syringe Calibra® Base Shade (2g), Translucent
  • Weight: 2 Gram
607064

  • Dental composite resin
Calibra® Esthetic Resin Cement, Base, Dark, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607063
In Commercial Distribution

  • D0026070630 ()

  • 1 Syringe Calibra® Base Shade (2g), Dark
  • Weight: 2 Gram
607063

  • Dental composite resin
Calibra® Esthetic Resin Cement, Base, Medium, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607062
In Commercial Distribution

  • D0026070620 ()

  • 1 Syringe Calibra® Base Shade (2g), Medium
  • Weight: 2 Gram
607062

  • Dental composite resin
Calibra® Esthetic Resin Cement, Base, Light, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607061
In Commercial Distribution

  • D0026070610 ()

  • 1 Syringe Calibra® Base Shade (2g), Light
  • Weight: 2 Gram
607061

  • Dental composite resin
Calibra® Esthetic Resin Cement Trial Kit
DENTSPLY INTERNATIONAL INC.
607057
In Commercial Distribution

  • D0026070571 ()

  • Weight: 2 Gram
  • 1 Syringe Base Shade Translucent, 1 Syringe Catalyst, 1 Bottle Activator, 1 Bottle Adhesive, and Accessories
607057

  • Dental composite resin
Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material, Fast Set Intro Kit Case
DENTSPLY INTERNATIONAL INC.
605710
In Commercial Distribution

  • D0026057101 ()

  • Weight: 454 Gram
  • Case of 9 Canisters Fast Set Intro Kit (454g each) contains: 1 Pouch Jeltrate® Chroma Material (454g), 1 Water Measure, 1 Powder Scoop
605710

  • Alginate dental impression material
Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material, Fast Set, Case of 12 pouches
DENTSPLY INTERNATIONAL INC.
605700
In Commercial Distribution

  • D0026057001 ()
  • D0026057000 ()

  • Weight: 454 Gram
  • Case of 12 Pouches Fast Set (454g each)
605700

  • Alginate dental impression material
Prime&Bond® NT™ Light Cured Dental Adhesive Unit Dose Package
DENTSPLY INTERNATIONAL INC.
634356
In Commercial Distribution

  • D0026343561 ()
  • D0026343560 ()

  • 80 Unit Doses Prime&Bond® NT™, 4 Unit Dose Holders, 100 Flocked Applicator tips
634356

  • Dentine adhesive
Self Cure Activator Refill Package
DENTSPLY INTERNATIONAL INC.
634354K
In Commercial Distribution

  • D002634354K1 ()

  • 1 Bottle (4.5 mL)
634354K

  • Dentine bonding agent/set
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
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
DENTSPLY INTERNATIONAL INC.
631400
In Commercial Distribution

  • D00263140042 ()
  • D0026314000 ()

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

  • Dental unfilled resin sealant/coating
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 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 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, 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
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