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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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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 Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
61E801
In Commercial Distribution

  • D00261E8010 ()
  • D00261E8011 ()
61E801

  • Silicone dental impression material
Algin-X™ Ultra Alginate Alternative Impression Material, Fast Set, 4 (50ml) Cartridge Refill
DENTSPLY INTERNATIONAL INC.
61E800
In Commercial Distribution

  • D00261E80082 ()
  • D00261E8001 ()
  • D00261E8000 ()

  • Total Volume: 50 Milliliter
  • 4 Algin-X™ Ultra Cartridges (50mL each) and 6 Mixing Tips
61E800

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

  • D00261C130P0 ()
  • D00261C130P1 ()
61C130P

  • 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
Calm-it™ Unit Dose Sample
DENTSPLY INTERNATIONAL INC.
61A100
Not in Commercial Distribution

  • D00261A1001 ()

  • 1 Calm-it™ Desensitizer Unit Dose
61A100

  • Dental cavity varnish
Regisil® Rigid Super Fast Set VPS Bite Reg Material (Purple), Cartridge System Refill Package
DENTSPLY INTERNATIONAL INC.
619425
In Commercial Distribution

  • D00261942582 ()
  • D0026194251 ()
  • D0026194250 ()

  • Total Volume: 50 Milliliter
  • 4 Cartridges (50mL each), 12 Mixing Tips
619425

  • Silicone dental impression material
FluoroCore® 2+ Introductory Kit
DENTSPLY INTERNATIONAL INC.
612600
In Commercial Distribution

  • D0026126001 ()
612600

  • 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® 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
Calibra® Veneer Cement Try-In Paste Accessory Pack
DENTSPLY INTERNATIONAL INC.
607300
In Commercial Distribution

  • D0026073001 ()

  • 5 Syringes Calibra® Veneer Try-In Paste (1.8g each) - 1 in each shade: Light, Medium, Dark, Opaque, Bleach
  • Weight: 1.8 Gram
607300

  • Dental composite resin
Calibra® Veneer Syringe Refill Package - Bleach Shade
DENTSPLY INTERNATIONAL INC.
607206
In Commercial Distribution

  • D0026072061 ()
607206

  • Dental composite resin
Calibra® Veneer Cement Light Cure Syringe Refill Package, Base, Translucent, 1 syringe (2g)
DENTSPLY INTERNATIONAL INC.
607204
In Commercial Distribution

  • D0026072040 ()

  • Weight: 2 Gram
  • 1 Syringe Light Cure Calibra® Veneer Cement (2g), Translucent
607204

  • Dental composite resin
Calibra® Ceram Adhesive Resin Cement Syringe Refill - Shade Bleach
DENTSPLY INTERNATIONAL INC.
607196
In Commercial Distribution

  • D0026071960 ()

  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
  • Weight: 4.5 Gram
607196

  • Dental composite resin
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