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

  • D0026077010 ()

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

  • 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 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 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, 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.
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 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, 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 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, 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® Ceram Adhesive Resin Cement Syringe Refill - Shade Translucent
DENTSPLY INTERNATIONAL INC.
607194
In Commercial Distribution

  • D0026071940 ()

  • Weight: 4.5 Gram
  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
607194

  • Dental composite resin
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 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 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 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 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, 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, 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
Calibra® Esthetic Resin Cement Trial Kit
DENTSPLY INTERNATIONAL INC.
607057
In Commercial Distribution

  • D0026070571 ()

  • Weight: 2 Gram
  • 1 Syringe Base Shade Translucent, 1 Syringe Catalyst, 1 Bottle Activator, 1 Bottle Adhesive, and Accessories
607057

  • Dental composite resin
Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material, Fast Set Intro Kit Case
DENTSPLY INTERNATIONAL INC.
605710
In Commercial Distribution

  • D0026057101 ()

  • Weight: 454 Gram
  • Case of 9 Canisters Fast Set Intro Kit (454g each) contains: 1 Pouch Jeltrate® Chroma Material (454g), 1 Water Measure, 1 Powder Scoop
605710

  • Alginate dental impression material
Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material, Fast Set, Case of 12 pouches
DENTSPLY INTERNATIONAL INC.
605700
In Commercial Distribution

  • D0026057001 ()
  • D0026057000 ()

  • Weight: 454 Gram
  • Case of 12 Pouches Fast Set (454g each)
605700

  • Alginate dental impression material
AutoMatrix Retainerless Matrix System Introductory Kit
DENTSPLY INTERNATIONAL INC.
663032
In Commercial Distribution

  • D0026630321 ()

  • 96x bands (24 each size) , 1x tightening device, 1x Snippers, 6x catch trays
663032

  • Dental matrix band, single-use
Palodent V3 Small WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659830V
In Commercial Distribution

  • D002662024V1 ()
  • D002662024V0 ()

  • 50x WedgeGuards (Small)
659830V

  • Dental wedge, single-use
Enhance PoGo Polishing System Cup Refill
DENTSPLY INTERNATIONAL INC.
662023
In Commercial Distribution

  • D0026620231 ()
  • D0026620230 ()

  • 40x polishing cups
662023

  • Dental abrasive disk, reusable
Palodent V3 Large WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659850V
In Commercial Distribution

  • D002662022V1 ()
  • D002662022V0 ()

  • 50x WedgeGuards (Large)
659850V

  • Dental wedge, single-use
Palodent V3 Universal Rings Refill
DENTSPLY INTERNATIONAL INC.
659900V
In Commercial Distribution

  • D002659900V1 ()

  • 1x Universal Ring
659900V

  • Dental matrix band tensioner
Palodent Plus Sectional Matrix System Ring Refill
DENTSPLY INTERNATIONAL INC.
659900
In Commercial Distribution

  • D0026599001 ()

  • 1x Universal Ring
659900

  • Dental matrix band tensioner
Palodent Plus Sample
DENTSPLY INTERNATIONAL INC.
659890
In Commercial Distribution

  • D0026598901 ()

  • 1x Universal Ring, 5x Matrices (size 5.5mm), 5x Medium Wedges, 5x Medium Wedgeguards
659890

  • Dental matrix band tensioner
  • Dental matrix band, single-use
  • Dental wedge, single-use
Palodent Plus Trial Kit
DENTSPLY INTERNATIONAL INC.
659880
In Commercial Distribution

  • D0026598801 ()

  • 1x Universal Ring, 10x Matrices (5.5mm), 10x Medium Wedges, 10x Medium WedgeGuards, 5x SureFil® SDR® Compula® Tips (Universal shade), 1x Forceps, 1x Pin Tweezers
659880

  • Dental matrix band, single-use
  • Dental wedge, single-use
  • Rubber dam clamp forceps
  • Dental matrix band tensioner
  • Dental dressing forceps, reusable
Palodent V3 7.5mm Matrix Bands Refill
DENTSPLY INTERNATIONAL INC.
659860V
In Commercial Distribution

  • D002659860V1 ()
  • D002659860V0 ()

  • 50x Bands (7.5mm)
659860V

  • Dental matrix band, single-use
Palodent V3 Sectional Matrix System 7.5mm Matrix Bands Refill
DENTSPLY INTERNATIONAL INC.
659860
In Commercial Distribution

  • D0026598601 ()
  • D0026598600 ()

  • 50x Bands (7.5mm)
659860

  • Dental matrix band, single-use
Palodent Plus Large WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659850
In Commercial Distribution

  • D0026598501 ()
  • D0026598500 ()

  • 50x WedgeGuards (Large)
659850

  • Dental wedge, single-use
Palodent V3 Medium WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659840V
In Commercial Distribution

  • D002659840V1 ()
  • D002659840V0 ()

  • 50x WedgeGuards (Medium)
659840V

  • Dental wedge, single-use
Palodent Plus Medium WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659840
In Commercial Distribution

  • D0026598401 ()
  • D0026598400 ()

  • 50x WedgeGuards (Medium)
659840

  • Dental wedge, single-use
Palodent Plus Small WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659830
In Commercial Distribution

  • D0026598301 ()
  • D0026598300 ()

  • 50x WedgeGuards (Small)
659830

  • Dental wedge, single-use
Palodent V3 Pin Tweezers Refill
DENTSPLY INTERNATIONAL INC.
659820V
In Commercial Distribution

  • D002659820V1 ()

  • 1x Pin Tweezers
659820V

  • Rubber dam clamp forceps
  • Dental dressing forceps, reusable
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