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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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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

Esthet-X® HD - D0026306020

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 - D0026263921

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

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

Polytrays - D002624551031

Polytray Assorted Color
DENTSPLY INTERNATIONAL INC.
62455103
In Commercial Distribution

  • D002624551030 ()
  • D002624551031 ()
62455103

  • Dental impression tray, single-use

Polytrays - D002624551011

Polytray Upper 1 Blue
DENTSPLY INTERNATIONAL INC.
62455101
In Commercial Distribution

  • D002624551010 ()
  • D002624551011 ()
62455101

  • Dental impression tray, single-use

Polytrays - D002624550021

Polytray Lower 2 Yellow
DENTSPLY INTERNATIONAL INC.
62455002
In Commercial Distribution

  • D002624550020 ()
  • D002624550021 ()
62455002

  • Dental impression tray, single-use

SDR® Plus Bulk Fill Flowable - D00261C130P1

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

  • D00261C130P0 ()
  • D00261C130P1 ()
61C130P

  • Dental composite resin

SDR® Plus Bulk Fill Flowable - D00261C111P1

SDR® Plus Syringe Tips Refill
DENTSPLY INTERNATIONAL INC.
61C111P
In Commercial Distribution

  • D00261C111P0 ()
  • D00261C111P1 ()

  • 60 Syringe Tips
61C111P

  • Dental material mixing nozzle

SDR® flow+ Bulk Fill Flowable - D00261C111G1

SDR® flow+ Syringe Tips Refill
DENTSPLY INTERNATIONAL INC.
61C111G
In Commercial Distribution

  • D00261C111G0 ()
  • D00261C111G1 ()

  • 60 Syringe Tips
61C111G

  • Dental material mixing nozzle

SDR® Plus Bulk Fill Flowable - D00261C108P1

SDR® Plus Compula Refill - Shade A3
DENTSPLY INTERNATIONAL INC.
61C108P
In Commercial Distribution

  • D00261C108P0 ()
  • D00261C108P1 ()
61C108P

  • Dental composite resin

SDR® Plus Bulk Fill Flowable - D00261C107P1

SDR® Plus Compula Refill - Shade A2
DENTSPLY INTERNATIONAL INC.
61C107P
In Commercial Distribution

  • D00261C107P0 ()
  • D00261C107P1 ()
61C107P

  • Dental composite resin

Calibra® Abutment - D0026077010

Calibra® Abutment Resin Cement Sample
DENTSPLY INTERNATIONAL INC.
607701
In Commercial Distribution

  • D0026077010 ()

  • 1 Syringe (2g), 10 Mix Tips
607701

  • Dental composite resin

Calibra® Abutment - D0026077000

Calibra® Abutment Resin Cement Syringe Refill
DENTSPLY INTERNATIONAL INC.
607700
In Commercial Distribution

  • D0026077000 ()

  • 1 Syringe (4.5g), 10 Mix Tips
607700

  • Dental composite resin

Calibra® Veneer Esthetic Resin Cement - D0026075001

Calibra® Veneer Kit
DENTSPLY INTERNATIONAL INC.
607500
In Commercial Distribution

  • D0026075001 ()
607500

  • Dental composite resin

Calibra® Universal+ Versatile Resin Cement - D002607410NA1

Calibra® Universal+ Sample
DENTSPLY INTERNATIONAL INC.
607410NA
In Commercial Distribution

  • D002607410NA1 ()

  • 2 Syringes (4.5g each); 20 Mixing Tips
607410NA

  • Dental composite resin

Calibra® Universal Self-Adhesive Resin Cement - D0026074101

Calibra® Universal Sample Package
DENTSPLY INTERNATIONAL INC.
607410
In Commercial Distribution

  • D0026074101 ()

  • 1 Syringe (2g) and 10 Mixing Tips
607410

  • Dental composite resin

Calibra® Universal+ Versatile Resin Cement - D002607407NA1

Calibra® Universal+ Syringe Refill - Bleach Shade
DENTSPLY INTERNATIONAL INC.
607407NA
In Commercial Distribution

  • D002607407NA0 ()
  • D002607407NA1 ()

  • 2 Syringes (4.5g each); 20 Mixing Tips
607407NA

  • Dental composite resin

Calibra® Universal Self-Adhesive Resin Cement - D0026074071

Calibra® Universal Dual Cure Automix Syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607407
In Commercial Distribution

  • D0026074071 ()
  • D0026074070 ()

  • 2 Syringes (4.5g) each and 20 Mixing Tips
  • Weight: 4.5 Gram
607407

  • Dental composite resin

Calibra® Universal+ Versatile Resin Cement - D002607406NA1

Calibra® Universal+ Syringe Refill - Opaque Shade
DENTSPLY INTERNATIONAL INC.
607406NA
In Commercial Distribution

  • D002607406NA0 ()
  • D002607406NA1 ()

  • 2 Syringes (4.5g each); 20 Mixing Tips
607406NA

  • Dental composite resin

Calibra® Universal Self-Adhesive Resin Cement - D0026074061

Calibra® Universal Cement Dual Cure Automix Syringe Refill Package, Opaque, 2 syringe (4.5g)
DENTSPLY INTERNATIONAL INC.
607406
In Commercial Distribution

  • D0026074061 ()
  • D0026074060 ()

  • Weight: 4.5 Gram
  • 2 Dual Cure AutoMix Syringes (4.5g) - Opaque - and 20 Mixing Tips
607406

  • Dental composite resin

Calibra® Universal+ Versatile Resin Cement - D002607405NA1

Calibra® Universal+ Syringe Refill - Translucent Shade
DENTSPLY INTERNATIONAL INC.
607405NA
In Commercial Distribution

  • D002607405NA0 ()
  • D002607405NA1 ()

  • 2 Syringes (4.5g each); 20 Mixing Tips
607405NA

  • Dental composite resin

Calibra® Universal Self-Adhesive Resin Cement - D0026074051

Calibra® Universal Cement Dual Cure Automix Syringe Refill Package, Translucent, 2 syringe (4.5g)
DENTSPLY INTERNATIONAL INC.
607405
In Commercial Distribution

  • D0026074051 ()
  • D0026074050 ()

  • 2 Dual Cure AutoMix Syringes (4.5g) - Translucent - and 20 Mixing Tips
  • Weight: 4.5 Gram
607405

  • Dental composite resin

Calibra® Universal+ Versatile Resin Cement - D002607403NA1

Calibra® Universal+ Syringe Refill - Medium Shade
DENTSPLY INTERNATIONAL INC.
607403NA
In Commercial Distribution

  • D002607403NA0 ()
  • D002607403NA1 ()

  • 2 Syringes (4.5g each); 20 Mixing Tips
607403NA

  • Dental composite resin

Calibra® Universal Self-Adhesive Resin Cement - D0026074031

Calibra® Universal Cement Dual Cure Automix Syringe Refill Package, Medium, 2 syringe (4.5g)
DENTSPLY INTERNATIONAL INC.
607403
In Commercial Distribution

  • D0026074031 ()
  • D0026074030 ()

  • Weight: 4.5 Gram
  • 2 Dual Cure AutoMix Syringes (4.5g) - Medium - and 20 Mixing Tips
607403

  • Dental composite resin

Calibra® Universal Self-Adhesive Resin Cement - D0026074021

Calibra® Universal Cement Dual Cure Automix Syringe Refill Package, Light, 2 syringe (4.5g)
DENTSPLY INTERNATIONAL INC.
607402
In Commercial Distribution

  • D0026074021 ()
  • D0026074020 ()

  • Weight: 4.5 Gram
  • 2 Dual Cure AutoMix Syringes (4.5g) - Light - and 20 Mixing Tips
607402

  • Dental composite resin

Calibra® Universal+ Versatile Resin Cement - D002607400NA1

Calibra® Universal+ Syringe Introductory Kit
DENTSPLY INTERNATIONAL INC.
607400NA
In Commercial Distribution

  • D002607400NA0 ()
  • D002607400NA1 ()

  • 5 Syringes (4.5g each), 1 in each shade (Light, Medium, Translucent, Opaque, Bleach); 50 Mixing Tips
607400NA

  • Dental composite resin

Calibra® Universal Self-Adhesive Resin Cement - D0026074001

Calibra® Universal Syringe Introductory Kit
DENTSPLY INTERNATIONAL INC.
607400
In Commercial Distribution

  • D0026074001 ()

  • 5 Dual Cure AutoMix Syringes (4.5g) - 1 each shade: Light, Medium, Translucent, Opaque, Bleach; 50 Mixing Tips
  • Weight: 4.5 Gram
607400

  • Dental composite resin

Calibra® Veneer Esthetic Resin Cement - D0026073061

Calibra® Veneer Try-In Paste Syringe Refill Package - Bleach Shade
DENTSPLY INTERNATIONAL INC.
607306
In Commercial Distribution

  • D0026073060 ()
  • D0026073061 ()
607306

  • Dental composite resin

Calibra® Veneer Esthetic Resin Cement - D0026073051

Calibra® Veneer Cement, Try-In Paste Refill Package, Opaque, 2 syringe (1.8g)
DENTSPLY INTERNATIONAL INC.
607305
In Commercial Distribution

  • D0026073051 ()
  • D0026073050 ()

  • 2 Syringes Calibra® Veneer Try-In Paste (1.8g), Opaque
  • Weight: 1.8 Gram
607305

  • Dental composite resin

Calibra® Veneer Esthetic Resin Cement - D0026073021

Calibra® Veneer Cement, Try-In Paste Refill Package, Medium, 2 syringe (1.8g)
DENTSPLY INTERNATIONAL INC.
607302
In Commercial Distribution

  • D0026073021 ()
  • D0026073020 ()

  • 2 Syringes Calibra® Veneer Try-In Paste (1.8g), Medium
  • Weight: 1.8 Gram
607302

  • Dental composite resin

Calibra® Veneer Esthetic Resin Cement - D0026073001

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 Esthetic Resin Cement - D0026072050

Calibra® Veneer Cement Light Cure Syringe Refill Package, Base, Opaque, 1 syringe (2g)
DENTSPLY INTERNATIONAL INC.
607205
In Commercial Distribution

  • D0026072050 ()

  • 1 Syringe Light Cure Calibra® Veneer Cement (2g), Opaque
  • Weight: 2 Gram
607205

  • Dental composite resin

Calibra® Veneer Esthetic Resin Cement - D0026072040

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® Veneer Esthetic Resin Cement - D0026072020

Calibra® Veneer Cement Light Cure Syringe Refill Package, Base, Medium, 1 syringe (2g)
DENTSPLY INTERNATIONAL INC.
607202
In Commercial Distribution

  • D0026072020 ()

  • 1 Syringe Light Cure Calibra® Veneer Cement (2g), Medium
  • Weight: 2 Gram
607202

  • Dental composite resin

Calibra® Veneer Esthetic Resin Cement - D0026072010

Calibra® Veneer Cement Light Cure Syringe Refill Package, Base, Light, 1 syringe (2g)
DENTSPLY INTERNATIONAL INC.
607201
In Commercial Distribution

  • D0026072010 ()

  • 1 Syringe Light Cure Calibra® Veneer Cement (2g), Light
  • Weight: 2 Gram
607201

  • Dental composite resin

Calibra® Ceram Adhesive Resin Cement - D0026071960

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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