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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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PalodentSectional Matrix System 100 Standard Matrices Refill
DENTSPLY INTERNATIONAL INC.
659010
In Commercial Distribution

  • D0026590101 ()
  • D0026590100 ()

  • 100x Standard Matrices
659010

  • Dental matrix band, single-use
Lynal® Tissue Conditioner & Temporary Reliner Package
DENTSPLY INTERNATIONAL INC.
653006
In Commercial Distribution

  • D0026530060 ()

  • Total Volume: 90 Milliliter
  • Weight: 120 Gram
  • 1 Powder (120g), 1 Liquid (90 mL), 1 Separator (15mL), and Accessories
653006

  • Denture reliner, soft, professional
Caulk® 34% Tooth Conditioner Gel Syringe Refill
DENTSPLY INTERNATIONAL INC.
646125
In Commercial Distribution

  • D00264612562 ()
  • D0026461251 ()
  • D0026461250 ()

  • Total Volume: 3 Milliliter
  • 2 Syringes Caulk® Tooth Conditioner Gel (3mL each) and 25 Applicator Tips
646125

  • Dental etching solution
Amalgam Bonding Accessory Kit
DENTSPLY INTERNATIONAL INC.
634402
In Commercial Distribution

  • D0026344020 ()
634402

  • Dentine bonding agent/set
Prime&Bond® NT™ Light Cured Dental Adhesive Unit Dose Package
DENTSPLY INTERNATIONAL INC.
634356
In Commercial Distribution

  • D0026343561 ()
  • D0026343560 ()

  • 80 Unit Doses Prime&Bond® NT™, 4 Unit Dose Holders, 100 Flocked Applicator tips
634356

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

  • D002634354K1 ()

  • 1 Bottle (4.5 mL)
634354K

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

  • D0026343540 ()

  • Total Volume: 4.5 Milliliter
  • One 4.5mL bottle Self Cure Activator
634354

  • Dentine adhesive
Prime&Bond® NT™ Nano-Technology Dental Adhesive Dual Cure Introductory Kit
DENTSPLY INTERNATIONAL INC.
634353
In Commercial Distribution

  • D0026343531 ()

  • Total Volume: 4.5 Milliliter
  • 1 Bottle Adhesive, 1 Bottle Activator, 1 Syringe Tooth Conditioner Gel, 25 Applicator Tips, 1 Brush Handle, 80 Disposable Brush Tips, 1 Dispensing Well
634353

  • Dentine adhesive
Total Etch Adhesive, 2 (4.5ml) Bottle Refill Package
DENTSPLY INTERNATIONAL INC.
634352
In Commercial Distribution

  • D00263435262 ()
  • D0026343521 ()
  • D0026343520 ()

  • Total Volume: 4.5 Milliliter
  • 2 Bottles Total Etch Adhesive (4.5mL)
634352

  • Dentine adhesive
Prime&Bond® NT™ Total Etch Adhesive Bottle Economy Package
DENTSPLY INTERNATIONAL INC.
634351
In Commercial Distribution

  • D00263435162 ()
  • D0026343511 ()

  • Total Volume: 3 Milliliter
  • 3 Bottles Adhesive, 120 Disposable Brush Tips, 1 Brush Handle, 2 Syringes Tooth Conditioner Gel, 75 Applicator Tips (Needles), 1 Dispensing Well
  • Total Volume: 4.5 Milliliter
634351

  • Dentine adhesive
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