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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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Palodent® 360 - D0026596011

Palodent® 360 Matrice Refill - Size 4.5mm
DENTSPLY INTERNATIONAL INC.
659601
In Commercial Distribution

  • D0026596010 ()
  • D0026596011 ()

  • 48 Matrices, Size 4.5mm (Dark Blue)
659601

  • Dental matrix band, single-use

Palodent® 360 - D002659600V0

Palodent® 360 Intro Kit with Palodent® V3
DENTSPLY INTERNATIONAL INC.
659600V
In Commercial Distribution

  • D002659600V0 ()

  • 100 Matrices, 75 Wedges, 30 WedgeGuards
659600V

  • Dental matrix band, single-use

Palodent® 360 - D0026596000

Palodent® 360 Intro Kit with Palodent® Plus
DENTSPLY INTERNATIONAL INC.
659600
In Commercial Distribution

  • D0026596000 ()

  • 100 Matrices, 75 Wedges, 30 WedgeGuards
659600

  • Dental matrix band, single-use

SmartLite® Pro - D0026444401

SmartLite® Pro-Endo Resto Kit
DENTSPLY INTERNATIONAL INC.
644440
In Commercial Distribution

  • D0026444401 ()

  • Handpiece with cure tip, transillumination tip, batteries, charging base, accessories box, EndoActivator attachment with 25 small tips, 25 medium tips, 25 medium long tips, and 100 barrier sleeves
644440

  • Dental/surgical polymerization lamp

TPH®3 Micro Matrix Restorative - D0026427061

TPH®3 Easy-Twist Syringe Introductory Kit
DENTSPLY INTERNATIONAL INC.
642706
Not in Commercial Distribution

  • D0026427061 ()

  • Weight: 3 Gram
  • Total Volume: 3 Milliliter
  • 8 TPH3 Syringes, 5 P&B Unit Doses, 1 Prisma Gloss Fine and Extrafine Syringe, 1 syringe Tooth Cond Gel, 1 shade guide, 25 polishing cups, 1 mandrel, Enhance Discs, Cups, & Points, 5 App Tips
642706

  • Dental composite resin

TPH®3 Micro Matrix Restorative - D0026427011

TPH®3 Compules® Tips Intro System
DENTSPLY INTERNATIONAL INC.
642701
Not in Commercial Distribution

  • D0026427011 ()

  • 38 Compules Tips, 1 gun, 1 shade guide, 5 P&B Unit Doses, Discs, Cups, and Points, 1 syringe Tooth Cond Gel, 25 Needles, 1 Syringe Prisma Gloss Fine & Extrafine, 5 Tips, 25 Polishing Cups, 1 Mandrel
642701

  • Dental composite resin

TPH®3 Micro Matrix Restorative - D0026427001

TPH®3 Compules® Tips Complete Organizer System
DENTSPLY INTERNATIONAL INC.
642700
Not in Commercial Distribution

  • D0026427001 ()

  • 96 Compules Tips, 1 gun, 1 Shade Guide System, 1 syringe Tooth Cond Gel, 10 P&B Unit Doses, 1 syringe each of TPH3, Prisma Gloss Fine & Extrafine, Enhance Finishers, 1 Mandrel, Cups, Tips & Needles
642700

  • Dental composite resin

Dentsply Sirona - D0026344020

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

  • D0026344020 ()
634402

  • Dentine bonding agent/set

Self Cure Activator - D002634354K1

Self Cure Activator Refill Package
DENTSPLY INTERNATIONAL INC.
634354K
In Commercial Distribution

  • D002634354K1 ()

  • 1 Bottle (4.5 mL)
634354K

  • Dentine bonding agent/set

Esthet-X® HD High Definition Micro Matrix Restorative - D0026306071

Esthet-X® HD High Definition Micro Matrix Restorative Total-Etch Direct Restorative Kit
DENTSPLY INTERNATIONAL INC.
630607
Not in Commercial Distribution

  • D0026306071 ()

  • Weight: 0.25 Gram
  • 6 Compules® Tips, 1 Compules® Tips Gun, 3 Compula® Tips, Enhance® Finishers, 6 Bond Unit Doses, 1 Unit Dose Holder, 6 Flocked Applicator Tips, 1 Syringe Tooth Cond Gel, 25 App Tips
  • Total Volume: 3 Milliliter
630607

  • Dental composite resin
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