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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® 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® 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® 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, 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 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
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® 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 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
Aquasil Ultra+ digit Power LV RS Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678696
In Commercial Distribution

  • D0026786960 ()
  • D0026786961 ()
678696

  • Silicone dental impression material
Aquasil® Ultra+ Introductory Kit
DENTSPLY INTERNATIONAL INC.
678695
In Commercial Distribution

  • D0026786951 ()

  • 2 AU+ Heavy FS 50mL cartridges, 1 AU+ LV FS 50mL cartridge, 1 AU+ XLV FS 50mL cartridge, 12 mix tips, 6 intraoral tips, 1 bottle (14mL) Caulk tray adhesive, 1 AU+ digit LV/XLV FS evaulator kit
  • Total Volume: 50 Milliliter
678695

  • Silicone dental impression material
Aquasil Ultra+ digit Power LV FS Small Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678694
In Commercial Distribution

  • D0026786940 ()
  • D0026786941 ()
678694

  • Silicone dental impression material
Aquasil Ultra+ digit Power XLV RS Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678693
In Commercial Distribution

  • D0026786930 ()
  • D0026786931 ()
678693

  • Silicone dental impression material
Aquasil® Ultra+ Rigid Fast Set DECA 5:1 (2-pack)
DENTSPLY INTERNATIONAL INC.
678688
In Commercial Distribution

  • D00267868832 ()
  • D0026786881 ()
  • D0026786880 ()

  • Total Volume: 380 Milliliter
  • 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring
678688

  • Silicone dental impression material
Aquasil® Ultra+ Heavy Regular Set DECA 5:1 (2-pack)
DENTSPLY INTERNATIONAL INC.
678686
In Commercial Distribution

  • D00267868632 ()
  • D0026786861 ()
  • D0026786860 ()

  • 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring
  • Total Volume: 380 Milliliter
678686

  • Silicone dental impression material
Aquasil® Ultra+ Heavy Fast Set DECA 5:1 (2-pack)
DENTSPLY INTERNATIONAL INC.
678684
In Commercial Distribution

  • D00267868432 ()
  • D0026786841 ()
  • D0026786840 ()

  • Total Volume: 380 Milliliter
  • 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring
678684

  • Silicone dental impression material
Aquasil® Ultra+ Medium Regular Set DECA 5:1 (2-pack)
DENTSPLY INTERNATIONAL INC.
678682
In Commercial Distribution

  • D00267868232 ()
  • D0026786821 ()
  • D0026786820 ()

  • Total Volume: 380 Milliliter
  • 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring
678682

  • Silicone dental impression material
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