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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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Prisma® Gloss™ - D0026240251

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 - D0026240201

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 - D0026240051

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® Radiopaque Calcium Hydroxide Composition - D0026231171

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 - D0026202010

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 - D0026202001

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® DUO Blocks / Cerec® Zirconia - D00261N0101

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® Essentials featuring Preventive Solutions - D00261N0031

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® Duo (ZLS) Blocks - D00261N0021

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 featuring Zirconia Translucent Zirconium Oxice Blocks - D00261N0011

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 - D00261I0461

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™ Endodontic Fiber Post - D00261I0441

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™ Endodontic Fiber Post - D00261I0431

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™ Endodontic Fiber Post - D00261I0421

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™ Endodontic Fiber Post - D00261I0411

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™ Endodontic Fiber Post - D00261I0221

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™ Endodontic Fiber Post - D00261I0211

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 DECA™ - D00261E8101

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 - D00261E8021

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 Alginate Alternative - D00261E8011

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 - D00261E8001

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 Bulk Fill Flowable - D00261C106P1

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

  • D00261C106P0 ()
  • D00261C106P1 ()
61C106P

  • Dental composite resin

SDR® Plus Bulk Fill Flowable - D00261C104P1

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 Bulk Fill Flowable - D00261C103P1

SDR® Plus Compula ECO Refill
DENTSPLY INTERNATIONAL INC.
61C103P
In Commercial Distribution

  • D00261C103P0 ()
  • D00261C103P1 ()
61C103P

  • Dental composite resin

SDR® Plus Bulk Fill Flowable - D00261C101P1

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

  • D00261C101P0 ()
  • D00261C101P1 ()
61C101P

  • Dental composite resin

Calm-it™ Desensitizer - D00261A1001

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 Cartridge System - D0026194251

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+ Dual Cure Core Build-up Material + Fast Endodontic Post Cement - D0026126001

FluoroCore® 2+ Introductory Kit
DENTSPLY INTERNATIONAL INC.
612600
In Commercial Distribution

  • D0026126001 ()
612600

  • Dental composite resin

FluoroCore® 2+ Dual Cure Core Build-Up Material + Fast Endodontic Post Cement - D0026124061

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 Esthetic Resin Cement - D0026073041

Calibra® Veneer Cement, Try-In Paste Refill Package, Translucent, 2 syringe (1.8g)
DENTSPLY INTERNATIONAL INC.
607304
In Commercial Distribution

  • D0026073041 ()
  • D0026073040 ()

  • 2 Syringes Calibra® Veneer Try-In Paste (1.8g), Translucent
  • Weight: 1.8 Gram
607304

  • Dental composite resin

Calibra® Veneer Esthetic Resin Cement - D0026073011

Calibra® Veneer Cement, Try-In Paste Refill Package, Light, 2 syringe (1.8g)
DENTSPLY INTERNATIONAL INC.
607301
In Commercial Distribution

  • D0026073011 ()
  • D0026073010 ()

  • Weight: 1.8 Gram
  • 2 Syringes Calibra® Veneer Try-In Paste (1.8g), Light
607301

  • Dental composite resin

Calibra® Veneer Esthetic Resin Cement - D0026072061

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

  • D0026072061 ()
607206

  • Dental composite resin

Calibra® Ceram Adhesive Resin Cement - D0026071950

Calibra® Ceram Adhesive Resin Cement Syringe Refill - Shade Opaque
DENTSPLY INTERNATIONAL INC.
607195
In Commercial Distribution

  • D0026071950 ()

  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
  • Weight: 4.5 Gram
607195

  • Dental composite resin

Calibra® Ceram Adhesive Resin Cement - D0026071920

Calibra® Ceram Adhesive Resin Cement Syringe Refill - Shade Medium
DENTSPLY INTERNATIONAL INC.
607192
In Commercial Distribution

  • D0026071920 ()

  • Weight: 4.5 Gram
  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
607192

  • Dental composite resin

Calibra® Ceram Adhesive Resin Cement - D0026071910

Calibra® Ceram Adhesive Resin Cement Syringe Refill - Shade Light
DENTSPLY INTERNATIONAL INC.
607191
In Commercial Distribution

  • D0026071910 ()

  • Weight: 4.5 Gram
  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
607191

  • Dental composite resin

CEREC® Essentials with Celtra® Duo (ZLS) Blocks - D0026071031

CEREC® Essentials Combo Kit with Celtra® Duo (ZLS) Blocks
DENTSPLY INTERNATIONAL INC.
607103
Not in Commercial Distribution

  • D0026071031 ()

  • 4 blocks, 3 Firing Pads, 1 Syringe Coupling Agent, 1 Overglaze, 1 Stain & Glaze Liquid, 1 Calibra Ceram Syringe, 10 mix tips, 1 mixing well, 1 bottle Prime&Bond elect, 25 flocked applicator tips
607103

  • Dental appliance fabrication material, ceramic

Calibra® Ceram Adhesive Resin Cement - D0026071010

Calibra® Ceram Adhesive Resin Cement Syringe Sample Package
DENTSPLY INTERNATIONAL INC.
607101
In Commercial Distribution

  • D0026071010 ()

  • 1 Dual Cure AutoMix Syringe (2g) Shade Translucent and 10 Mixing Tips
  • Weight: 2 Gram
607101

  • Dental composite resin

Calibra® Cement - D0026070861

Calibra® Cement Automix Syringe Mixing Tip Refill
DENTSPLY INTERNATIONAL INC.
607086
In Commercial Distribution

  • D0026070861 ()
  • D0026070860 ()

  • 50 Mixing Tips
607086

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070850

Calibra® Esthetic Resin Cement, Dual Cure Automix, Opaque, 1 (4.5g) syringe Refill
DENTSPLY INTERNATIONAL INC.
607085
In Commercial Distribution

  • D0026070850 ()

  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
  • Weight: 4.5 Gram
607085

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070840

Calibra® Esthetic Resin Cement, Dual Cure Automix, Translucent, 1 (4.5g) syringe Refill
DENTSPLY INTERNATIONAL INC.
607084
In Commercial Distribution

  • D0026070840 ()

  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
  • Weight: 4.5 Gram
607084

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070830

Calibra® Esthetic Resin Cement, Dual Cure Automix, Dark, 1 (4.5g) syringe Refill
DENTSPLY INTERNATIONAL INC.
607083
In Commercial Distribution

  • D0026070830 ()

  • Weight: 4.5 Gram
  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
607083

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070820

Calibra® Esthetic Resin Cement, Dual Cure Automix, Medium, 1 (4.5g) syringe Refill
DENTSPLY INTERNATIONAL INC.
607082
In Commercial Distribution

  • D0026070820 ()

  • Weight: 4.5 Gram
  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
607082

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070810

Calibra® Esthetic Resin Cement, Dual Cure Automix, Light, 1 (4.5g) syringe Refill
DENTSPLY INTERNATIONAL INC.
607081
In Commercial Distribution

  • D0026070810 ()

  • Weight: 4.5 Gram
  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
607081

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070800

Calibra® Esthetic Resin Cement, Silane Coupling Agent, 1 (3ml) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607080
In Commercial Distribution

  • D0026070800 ()

  • Total Volume: 3 Milliliter
  • 1 Syringe Calibra® Silane Coupling Agent (3mL) and 25 Applicator Needles
607080

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070690

Calibra® Esthetic Resin Cement, Catalyst, High Viscosity 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607069
In Commercial Distribution

  • D0026070690 ()

  • 1 Syringe Calibra® Catalyst (2g), High Viscosity
  • Weight: 2 Gram
607069

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070680

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 - D0026070650

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 - D0026070640

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 - D0026070630

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 - D0026070620

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
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