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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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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
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® 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® 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® 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 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, 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, 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 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® 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
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
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