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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 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
Amalgam Bonding Accessory Kit
DENTSPLY INTERNATIONAL INC.
634402
In Commercial Distribution

  • D0026344020 ()
634402

  • Dentine bonding agent/set
Self Cure Activator Refill Package
DENTSPLY INTERNATIONAL INC.
634354K
In Commercial Distribution

  • D002634354K1 ()

  • 1 Bottle (4.5 mL)
634354K

  • Dentine bonding agent/set
Prisma® Gloss™ Composite Polishing Paste System Syringe Refill - Extra Fine
DENTSPLY INTERNATIONAL INC.
631450
In Commercial Distribution

  • D00263145042 ()
  • D0026314500 ()

  • 1 Syringe Polishing Paste Extra Fine (4g)
  • Weight: 4 Gram
631450

  • Dental unfilled resin sealant/coating
Prisma® Gloss™ Composite Polishing Paste System Syringe Refill
DENTSPLY INTERNATIONAL INC.
631400
In Commercial Distribution

  • D00263140042 ()
  • D0026314000 ()

  • 1 Syringe Polishing Paste (4g)
  • Weight: 4 Gram
631400

  • Dental unfilled resin sealant/coating
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
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
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