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

  • D00261C111P0 ()
  • D00261C111P1 ()

  • 60 Syringe Tips
61C111P

  • Dental material mixing nozzle
SDR® flow+ Syringe Tips Refill
DENTSPLY INTERNATIONAL INC.
61C111G
In Commercial Distribution

  • D00261C111G0 ()
  • D00261C111G1 ()

  • 60 Syringe Tips
61C111G

  • Dental material mixing nozzle
SDR® Plus Compula Refill - Shade A3
DENTSPLY INTERNATIONAL INC.
61C108P
In Commercial Distribution

  • D00261C108P0 ()
  • D00261C108P1 ()
61C108P

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

  • D00261C107P0 ()
  • D00261C107P1 ()
61C107P

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

  • D00261C106P0 ()
  • D00261C106P1 ()
61C106P

  • Dental composite resin
SDR® Plus Bulk Fill Flowable
DENTSPLY INTERNATIONAL INC.
61C104P
In Commercial Distribution

  • D00261C104P1 ()

  • 1 Syringe (1 g), 3 Syringe Tips
61C104P

  • Dental composite resin
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 Resin Cement Syringe Refill
DENTSPLY INTERNATIONAL INC.
607700
In Commercial Distribution

  • D0026077000 ()

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

  • Dental composite resin
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+ 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 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+ 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 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+ 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 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+ 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 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 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+ 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 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 Try-In Paste Syringe Refill Package - Bleach Shade
DENTSPLY INTERNATIONAL INC.
607306
In Commercial Distribution

  • D0026073060 ()
  • D0026073061 ()
607306

  • Dental composite resin
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 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 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 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 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 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 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® 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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
Calibra® Esthetic Resin Cement, Base, Light, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607061
In Commercial Distribution

  • D0026070610 ()

  • 1 Syringe Calibra® Base Shade (2g), Light
  • Weight: 2 Gram
607061

  • Dental composite resin
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
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