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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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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
Seal & Protect™ Protective Sealant for Exposed Dentin. Contains: 2 Holders, 50 Brush Stixx
Dentsply Professional
658010
In Commercial Distribution

  • D0036580101 ()


  • Dental unfilled resin sealant/coating
DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Refill Kit. Also contains: Delton® Syringes, EZ Etch Syringe, EZ Tips, and Syringe Sleeves.
Dentsply Professional
310201
In Commercial Distribution

  • D0033102012 ()
  • D0033102011 ()

  • Weight: 1.9 Gram


  • Cable/lead/sensor/probe cover, non-sterile
  • Dental composite resin
DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Also contains: Delton® Syringes, EZ Etch Syringe, EZ Tips, and Syringe Sleeves.
Dentsply Professional
310101
In Commercial Distribution

  • D0033101012 ()
  • D0033101011 ()

  • Weight: 1.9 Gram


  • Cable/lead/sensor/probe cover, non-sterile
  • Dental composite resin
DELTON® PLUS Pit & Fissure Sealant with Fluoride Direct Delivery System Light Curing, Opaque. Contents: 50 DDS Cartridges of 4 ml.
Dentsply Professional
2896
In Commercial Distribution

  • D00328962 ()
  • D00328961 ()
  • D00328960 ()


  • Dental composite resin
DELTON® PLUS Pit & Fissure Sealant with FLUORIDE Direct Delivery System Light Curing, Opaque. Contents: 1 DDS Autoclavable Applicator, 50 Cartridges of 4 ml Sealant, EZ Etch Syringe of 3ml, 25 Etch Brush Tips.
Dentsply Professional
2894
In Commercial Distribution

  • D00328942 ()
  • D00328941 ()


  • Dental composite resin
DELTON® Regular Kit Light Curing Pit & Fissure Sealant, Opaque. Contents: 2 sealant bottles of 2.mL, Etchant bottle of 7 mL, Applicator with Tubes, Disposable Mixing Trays.
Dentsply Professional
27975
In Commercial Distribution

  • D003279752 ()
  • D003279751 ()


  • Dental unfilled resin sealant/coating
DELTON® Regular Kit Light Curing Pit and Fissure Sealant, Clear. Contents: 2 sealant bottles of 2.mL, Etchant bottle of 7 mL, Applicator with Tubes, Disposable Mixing Trays.
Dentsply Professional
27965
In Commercial Distribution

  • D003279652 ()
  • D003279651 ()


  • Dental unfilled resin sealant/coating
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