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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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
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 Celtra® Chairside Consumables Kit
DENTSPLY INTERNATIONAL INC.
61N002
Not in Commercial Distribution

  • D00261N0021 ()

  • 12 Blocks, 3 Firing Pads, 1 Syr. Calibra Ceram w/10 mix tips, 1 bottle Prime&Bond elect, 25 flocked app. tips, 1 disp. well, 1 syr. Coupling Agent w/25 disp. app. needles, 1 Stain & Glaze Kit
61N002

  • Dental appliance fabrication material, ceramic
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 Endodontic Fiber Posts Sample (Size #2 Red)
DENTSPLY INTERNATIONAL INC.
61I046
In Commercial Distribution

  • D00261I0461 ()

  • 5x posts (Size #2 Red) and 3x drills (Size #2 Red)
61I046

  • Root canal post, preformed
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 3 (blue)
DENTSPLY INTERNATIONAL INC.
61i043
In Commercial Distribution

  • D00261I0430 ()
  • D00261I0431 ()

  • 3 Drills (Size #3 Blue)
61i043

  • 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
FluoroPost™ Precision Drill Refill - Size 1 (yellow)
DENTSPLY INTERNATIONAL INC.
61i041
In Commercial Distribution

  • D00261I0410 ()
  • D00261I0411 ()

  • 3 Drills (Size #1 Yellow)
61i041

  • Fixture/appliance dental drill bit, reusable
FluoroPost™ Peaso Reamer Refill - Size 2 (for post #3 and #4)
DENTSPLY INTERNATIONAL INC.
61i021
In Commercial Distribution

  • D00261I0220 ()
  • D00261I0221 ()

  • 3 FluoroPost™ Precision Drills - Size 2
61i022

  • Crown surgical drill bit, reusable
FluoroPost™ Peaso Reamer Refill - Size 1 (for post #1 and #2)
DENTSPLY INTERNATIONAL INC.
61i021
In Commercial Distribution

  • D00261I0210 ()
  • D00261I0211 ()

  • 3 FluoroPost™ Precision Drills - Size 1
61i021

  • Crown surgical drill bit, reusable
Algin-X™ Ultra Alginate Alternative Impression Material, Fast Set, 2 (380ml) DECA™ Cartridge Standard Pack
DENTSPLY INTERNATIONAL INC.
61E810
In Commercial Distribution

  • D00261E81082 ()
  • D00261E8101 ()
  • D00261E8100 ()

  • 2 Cartridges (380ml each), 20 Dynamic Mixing Tips, 1 Bayonet Locking Ring
  • Total Volume: 380 Milliliter
61E810

  • Silicone dental impression material
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
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