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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® flow+ Bulk Fill Flowable - D00261C111G1

SDR® flow+ Syringe Tips Refill
DENTSPLY INTERNATIONAL INC.
61C111G
In Commercial Distribution

  • D00261C111G0 ()
  • D00261C111G1 ()

  • 60 Syringe Tips
61C111G

  • Dental material mixing nozzle

Calm-it™ Desensitizer - D00261A1001

Calm-it™ Unit Dose Sample
DENTSPLY INTERNATIONAL INC.
61A100
Not in Commercial Distribution

  • D00261A1001 ()

  • 1 Calm-it™ Desensitizer Unit Dose
61A100

  • Dental cavity varnish

FluoroCore® 2+ Dual Cure Core Build-up Material + Fast Endodontic Post Cement - D0026126001

FluoroCore® 2+ Introductory Kit
DENTSPLY INTERNATIONAL INC.
612600
In Commercial Distribution

  • D0026126001 ()
612600

  • Dental composite resin

Compspan™ Composite Luting Cement - D0026551001

Compspan™ Composite Luting Cement Complete Package
DENTSPLY INTERNATIONAL INC.
655100
In Commercial Distribution

  • D0026551001 ()

  • Weight: 5 Gram
  • 1 base paste, 1 catalyst paste, 1 self-cure bonding agent base liquid, 1 self-cure bonding agent catalyst liquid, 1 bottle tooth conditioner gel, and accessories
655100

  • Dental composite resin

Aquasil Ultra LV Fast Set Smart Wetting® Impression Material - D0026787801

Aquasil Ultra LV Fast Set Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
678780
Not in Commercial Distribution

  • D00267878082 ()
  • D0026787801 ()
  • D0026787800 ()

  • 4 LV cartridges (50ml), 24 Mixing Tips, 24 Intra Oral Tips
  • Total Volume: 50 Milliliter
678780

  • Silicone dental impression material

Topex® Prophy Paste - D687AD30001FG1

Topex® Prophy Paste Cherry Coarse Cups - 24 Cartons of 200 Cups
DENTSPLY INTERNATIONAL INC.
AD30001FG
In Commercial Distribution

  • D687AD30001FG2 ()
  • D687AD30001FG1 ()
  • D687AD30001FG0 ()

  • 24 Cartons of 200 Cups
AD30001FG

  • Dentifrice

Aquasil Ultra XLV Fast Set Smart Wetting® Impression Material - D0026788821

Aquasil Ultra XLV Fast Set Smart Wetting® Impression Material Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
678882
Not in Commercial Distribution

  • D00267888282 ()
  • D0026788821 ()
  • D0026788820 ()

  • Total Volume: 50 Milliliter
  • 4 XLV FS Cartridges (50ml), 24 Mixing Tips, 24 Intra Oral Tips
678882

  • Silicone dental impression material

Aquasil Ultra Heavy Smart Wetting® Impression Material - D0026785861

Aquasil Ultra Smart Wetting® Impression Material Heavy Regular Set DECA™ Intro Kit
DENTSPLY INTERNATIONAL INC.
678586
Not in Commercial Distribution

  • D0026785861 ()

  • Total Volume: 50 Milliliter
  • 1 Aquasil Ultra Heavy Cartridge (380ml), 1 Aquasil Ultra XLV Cartridge (50ml), 20 Mixing Tips, 1 Bayonet Ring, 12 Mixing Tips, 24 Intraoral Tips
  • Total Volume: 380 Milliliter
678586

  • Silicone dental impression material

Aquasil Ultra Fast Set Edentulous Smart Wetting® Impression Material - D0026781771

Aquasil Ultra Fast Set Edentulous Smart Wetting® Impression Material Introductory Kit with Massad™ Edentulous Impression Trays Kit
DENTSPLY INTERNATIONAL INC.
678177
Not in Commercial Distribution

  • D0026781771 ()

  • Total Volume: 50 Milliliter
  • 2 Cartridges Monophase FS, 2 Cartridges LV FS, 2 Cartridges XLV FS, 2 Cartridges Rigid FS, 24 Mixing Tips, 1 Bottle Tray Adhesive, 1 Massad™ Edentulous Impression Trays Kit
678177

  • Silicone dental impression material

Esthet-X®flow Liquid Micro Hybrid - D0026481011

Esthet-X®flow Liquid Micro Hybrid Compula® Tips Introductory Kit
DENTSPLY INTERNATIONAL INC.
648101
Not in Commercial Distribution

  • D0026481011 ()

  • 24 Tips, 1 Tips Gun, 1 Syringe Tooth Cond Gel, 25 Applicator Needles, 20 Unit Doses Adhesive, 1 Unit Dose Holder, 20 Applicator Tips, Enhance Finishing Sample, Polishing Sample, Tips Sample
  • Weight: 0.25 Gram
648101

  • Dental composite resin
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