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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, 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
AutoMatrix Retainerless Matrix System Introductory Kit
DENTSPLY INTERNATIONAL INC.
663032
In Commercial Distribution

  • D0026630321 ()

  • 96x bands (24 each size) , 1x tightening device, 1x Snippers, 6x catch trays
663032

  • Dental matrix band, single-use
Palodent V3 Small WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659830V
In Commercial Distribution

  • D002662024V1 ()
  • D002662024V0 ()

  • 50x WedgeGuards (Small)
659830V

  • Dental wedge, single-use
Enhance PoGo Polishing System Cup Refill
DENTSPLY INTERNATIONAL INC.
662023
In Commercial Distribution

  • D0026620231 ()
  • D0026620230 ()

  • 40x polishing cups
662023

  • Dental abrasive disk, reusable
Palodent V3 Large WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659850V
In Commercial Distribution

  • D002662022V1 ()
  • D002662022V0 ()

  • 50x WedgeGuards (Large)
659850V

  • Dental wedge, single-use
Palodent V3 Universal Rings Refill
DENTSPLY INTERNATIONAL INC.
659900V
In Commercial Distribution

  • D002659900V1 ()

  • 1x Universal Ring
659900V

  • Dental matrix band tensioner
Palodent Plus Sectional Matrix System Ring Refill
DENTSPLY INTERNATIONAL INC.
659900
In Commercial Distribution

  • D0026599001 ()

  • 1x Universal Ring
659900

  • Dental matrix band tensioner
Palodent Plus Sample
DENTSPLY INTERNATIONAL INC.
659890
In Commercial Distribution

  • D0026598901 ()

  • 1x Universal Ring, 5x Matrices (size 5.5mm), 5x Medium Wedges, 5x Medium Wedgeguards
659890

  • Dental matrix band tensioner
  • Dental matrix band, single-use
  • Dental wedge, single-use
Palodent Plus Trial Kit
DENTSPLY INTERNATIONAL INC.
659880
In Commercial Distribution

  • D0026598801 ()

  • 1x Universal Ring, 10x Matrices (5.5mm), 10x Medium Wedges, 10x Medium WedgeGuards, 5x SureFil® SDR® Compula® Tips (Universal shade), 1x Forceps, 1x Pin Tweezers
659880

  • Dental matrix band, single-use
  • Dental wedge, single-use
  • Rubber dam clamp forceps
  • Dental matrix band tensioner
  • Dental dressing forceps, reusable
Palodent V3 7.5mm Matrix Bands Refill
DENTSPLY INTERNATIONAL INC.
659860V
In Commercial Distribution

  • D002659860V1 ()
  • D002659860V0 ()

  • 50x Bands (7.5mm)
659860V

  • Dental matrix band, single-use
Palodent V3 Sectional Matrix System 7.5mm Matrix Bands Refill
DENTSPLY INTERNATIONAL INC.
659860
In Commercial Distribution

  • D0026598601 ()
  • D0026598600 ()

  • 50x Bands (7.5mm)
659860

  • Dental matrix band, single-use
Palodent Plus Large WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659850
In Commercial Distribution

  • D0026598501 ()
  • D0026598500 ()

  • 50x WedgeGuards (Large)
659850

  • Dental wedge, single-use
Palodent V3 Medium WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659840V
In Commercial Distribution

  • D002659840V1 ()
  • D002659840V0 ()

  • 50x WedgeGuards (Medium)
659840V

  • Dental wedge, single-use
Palodent Plus Medium WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659840
In Commercial Distribution

  • D0026598401 ()
  • D0026598400 ()

  • 50x WedgeGuards (Medium)
659840

  • Dental wedge, single-use
Palodent Plus Small WedgeGuard Refill
DENTSPLY INTERNATIONAL INC.
659830
In Commercial Distribution

  • D0026598301 ()
  • D0026598300 ()

  • 50x WedgeGuards (Small)
659830

  • Dental wedge, single-use
Palodent V3 Pin Tweezers Refill
DENTSPLY INTERNATIONAL INC.
659820V
In Commercial Distribution

  • D002659820V1 ()

  • 1x Pin Tweezers
659820V

  • Rubber dam clamp forceps
  • Dental dressing forceps, reusable
Palodent V3 Forceps Refill
DENTSPLY INTERNATIONAL INC.
659810V
In Commercial Distribution

  • D002659810V1 ()

  • 1x Forceps
659810V

  • Rubber dam clamp forceps
  • Dental dressing forceps, reusable
Palodent Plus EZ Coat Introductory Kit
DENTSPLY INTERNATIONAL INC.
659670
In Commercial Distribution

  • D0026596701 ()

  • 20x each of matrix bands (5 sizes), 25x each of wedges (3 sizes), 10x each of wedge guards (3 sizes), 2x Rings, 1x Forceps, 1x Tweezers
659670

  • Dental matrix band, single-use
Palodent Plus EZ Coat 7.5mm Matrices Refill
DENTSPLY INTERNATIONAL INC.
659660
In Commercial Distribution

  • D0026596601 ()
  • D0026596600 ()

  • 50x Matrices (7.5mm)
659660

  • Dental matrix band, single-use
Palodent Plus EZ Coat 6.5mm Matrices Refill
DENTSPLY INTERNATIONAL INC.
659650
In Commercial Distribution

  • D0026596501 ()
  • D0026596500 ()

  • 50x Matrices (6.5mm)
659650

  • Dental matrix band, single-use
Palodent Plus EZ Coat 5.5mm Matrices Refill (90)
DENTSPLY INTERNATIONAL INC.
659640
In Commercial Distribution

  • D0026596401 ()
  • D0026596400 ()

  • 90x Matrices (5.5mm)
659640

  • Dental matrix band, single-use
Palodent Plus EZ Coat 5.5mm Matrices Refill
DENTSPLY INTERNATIONAL INC.
659630
In Commercial Distribution

  • D0026596301 ()
  • D0026596300 ()

  • 50x Matrices (5.5mm)
659630

  • Dental matrix band, single-use
Palodent Plus EZ Coat 4.5mm Matrices Refill
DENTSPLY INTERNATIONAL INC.
659620
In Commercial Distribution

  • D0026596201 ()
  • D0026596200 ()

  • 50x Matrices (4.5mm)
659620

  • Dental matrix band, single-use
Palodent® 360 Intro Kit
DENTSPLY INTERNATIONAL INC.
659607
In Commercial Distribution

  • D0026596070 ()

  • 48 Matrices (8 of 4.5mm, 24 of 5.5mm, 16 of 6.5mm)
659607

  • Dental matrix band, single-use
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
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