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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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CEREC® Essentials featuring Zirconia Translucent Zirconium Oxice Blocks - D00261N0011

CEREC® Essentials with Zirconia Chairside Consumables Kit
DENTSPLY INTERNATIONAL INC.
61N001
Not in Commercial Distribution

  • D00261N0011 ()

  • 12 CEREC Zirconia blocks, 2 syringes Calibra Universal Cement with 20 mix tips, 1 round dusting brush, 2 Scotch Bright brushes
61N001

  • Dental appliance fabrication material, ceramic

FluoroPost™ Endodontic Fiber Posts - D00261I0461

FluoroPost Endodontic Fiber Posts Sample (Size #2 Red)
DENTSPLY INTERNATIONAL INC.
61I046
In Commercial Distribution

  • D00261I0461 ()

  • 5x posts (Size #2 Red) and 3x drills (Size #2 Red)
61I046

  • Root canal post, preformed

FluoroPost™ Endodontic Fiber Post - D00261I0441

FluoroPost™ Precision Drill Refill - Size 4 (green)
DENTSPLY INTERNATIONAL INC.
61i044
In Commercial Distribution

  • D00261I0440 ()
  • D00261I0441 ()

  • 3 Drills (Size #4 Green)
61i044

  • Fixture/appliance dental drill bit, reusable

FluoroPost™ Endodontic Fiber Post - D00261I0431

FluoroPost™ Precision Drill Refill - Size 3 (blue)
DENTSPLY INTERNATIONAL INC.
61i043
In Commercial Distribution

  • D00261I0430 ()
  • D00261I0431 ()

  • 3 Drills (Size #3 Blue)
61i043

  • Fixture/appliance dental drill bit, reusable

FluoroPost™ Endodontic Fiber Post - D00261I0421

FluoroPost™ Precision Drill Refill - Size 2 (red)
DENTSPLY INTERNATIONAL INC.
61i042
In Commercial Distribution

  • D00261I0420 ()
  • D00261I0421 ()

  • 3 Drills (Size #2 Red))
61i042

  • Fixture/appliance dental drill bit, reusable

FluoroPost™ Endodontic Fiber Post - D00261I0411

FluoroPost™ Precision Drill Refill - Size 1 (yellow)
DENTSPLY INTERNATIONAL INC.
61i041
In Commercial Distribution

  • D00261I0410 ()
  • D00261I0411 ()

  • 3 Drills (Size #1 Yellow)
61i041

  • Fixture/appliance dental drill bit, reusable

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

Aqueduct SED - ACCCARTV101

The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON200) for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-101V
In Commercial Distribution

  • ACCCARTV101 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set
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