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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 - D002634354K1

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 - D0026343540

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 Light Cured Dental Adhesive - D0026343531

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™ Nano-Technology Light Cured Dental Adhesive - D0026343521

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™ Nano-Technology Light Cured Dental Adhesive - D0026343511

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 Light Cured Dental Adhesive - D0026343501

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 - D0026314500

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 - D0026314000

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 - D0026312031

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

Reprosil® Quixx Putty Vinyl Polysiloxane Impression Material - D0026262301

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

Enhance® Finishing System - D0026242551

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/Enhance® PoGo® Polishing System - D0026242051

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

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

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 - D00261C130P1

SDR® Plus Syringe Refill
DENTSPLY INTERNATIONAL INC.
61C130P
In Commercial Distribution

  • D00261C130P0 ()
  • D00261C130P1 ()
61C130P

  • Dental composite resin
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