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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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Enamelast - 00883205102911

Enamelast Syringe 20pk - Bubble Gum
ULTRADENT PRODUCTS, INC.
4367
Not in Commercial Distribution

  • 00883205102911 ()
4367

  • Dental coating, tooth-desensitizing

Enamelast - 00883205102904

Enamelast Syringe 2pk - Bubble Gum
ULTRADENT PRODUCTS, INC.
4366
Not in Commercial Distribution

  • 00883205102904 ()
4366

  • Dental coating, tooth-desensitizing

Enamelast - 00883205102898

Enamelast Unit Dose 5pk - Bubble Gum
ULTRADENT PRODUCTS, INC.
4364
In Commercial Distribution

  • 00883205102898 ()
4364

  • Dental coating, tooth-desensitizing

Enamelast - 00883205102867

Enamelast Syringe 20pk - Cool Mint
ULTRADENT PRODUCTS, INC.
4348
Not in Commercial Distribution

  • 00883205102867 ()
4348

  • Dental coating, tooth-desensitizing

Enamelast - 00883205102850

Enamelast Syringe 2pk - Cool Mint
ULTRADENT PRODUCTS, INC.
4349
Not in Commercial Distribution

  • 00883205102850 ()
4349

  • Dental coating, tooth-desensitizing

Enamelast - 00883205102843

Enamelast Unit Dose 5pk - Cool Mint
ULTRADENT PRODUCTS, INC.
4354
In Commercial Distribution

  • 00883205102843 ()
4354

  • Dental coating, tooth-desensitizing

Enamelast - 00883205102812

Enamelast Syringe 20pk - Orange Cream
ULTRADENT PRODUCTS, INC.
4347
Not in Commercial Distribution

  • 00883205102812 ()
4347

  • Dental coating, tooth-desensitizing

Enamelast - 00883205102805

Enamelast Syringe 2pk - Orange Cream
ULTRADENT PRODUCTS, INC.
4346
Not in Commercial Distribution

  • 00883205102805 ()
4346

  • Dental coating, tooth-desensitizing

Enamelast - 00883205102799

Enamelast Unit Dose 5pk - Orange Cream
ULTRADENT PRODUCTS, INC.
4345
In Commercial Distribution

  • 00883205102799 ()
4345

  • Dental coating, tooth-desensitizing

UltraEZ - 00883205102690

UltraEZ Tray Delivery, Upper/Lower Combo Kit
ULTRADENT PRODUCTS, INC.
5721
In Commercial Distribution

  • 00883205102690 ()
5721

  • Dental coating, tooth-desensitizing

UltraEZ - 00883205102652

UltraEz Mini Kit
ULTRADENT PRODUCTS, INC.
5743
In Commercial Distribution

  • 00883205102652 ()
5743

  • Dental coating, tooth-desensitizing

Enamelast - 00883205101754

Enamelast Unit Dose 5pk - Walterberry
ULTRADENT PRODUCTS, INC.
4526
In Commercial Distribution

  • 00883205101754 ()
4526

  • Dental coating, tooth-desensitizing

Rapid Response - 00722066000304

Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma.
BTNX Inc
HPY-13C15
In Commercial Distribution

  • 00722066000304 ()
  • 00722066004258 ()
HPY-13C15

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

laserwhite20 Whitening Gel - 00647529000113

laserwhite20 Whitening Gel contains 5 patient treatment kits. Each kit contains one syringe of whitening gel base, one syringe of gel activator, one syringe of liquid dam and one syringe of desensitizer. Accessories such as applicators are also included. The product is intended for use with Biolase diode lasers.
Biolase, Inc.
laserwhite20
In Commercial Distribution

  • 00647529000113 ()
  • 00647529000281 ()
7400030

  • Dental coating, tooth-desensitizing

KöR - 00850362007106

Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and all other desensitizing needs.
EVOLVE DENTAL TECHNOLOGIES, INC.
KöR Complete Desensitizer - 10mL
In Commercial Distribution

  • 00850362007106 ()

  • Total Volume: 10 Milliliter
10-1018

  • Dental coating, tooth-desensitizing

KöR - 00850362007090

Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and all other desensitizing needs.
EVOLVE DENTAL TECHNOLOGIES, INC.
KöR Complete Desensitizer - 3mL
In Commercial Distribution

  • 00850362007090 ()

  • Total Volume: 3 Milliliter
10-1016

  • Dental coating, tooth-desensitizing

KöR - 00850362007083

Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and all other desensitizing needs.
EVOLVE DENTAL TECHNOLOGIES, INC.
KöR Complete Desensitizer - 5mL
In Commercial Distribution

  • 00850362007083 ()

  • Total Volume: 5 Milliliter
10-1017

  • Dental coating, tooth-desensitizing

KöR - 00850362007076

KöR Teeth Desensitizer - 5ml
EVOLVE DENTAL TECHNOLOGIES, INC.
KöR Teeth Desensitizer - 5ml
In Commercial Distribution

  • 00850362007076 ()

  • Total Volume: 5 Milliliter
10-1012

  • Dental coating, tooth-desensitizing

KöR - 00850362007069

KöR Teeth Desensitizer - 2.5ml
EVOLVE DENTAL TECHNOLOGIES, INC.
KöR Teeth Desensitizer - 2.5ml
In Commercial Distribution

  • 00850362007069 ()

  • Total Volume: 2.5 Milliliter
10-1011

  • Dental coating, tooth-desensitizing

KöR - 00850362007052

KöR Desensitizer-10ml
EVOLVE DENTAL TECHNOLOGIES, INC.
KöR Desensitizer-10ml
In Commercial Distribution

  • 00850362007052 ()

  • Total Volume: 10 Milliliter
10-1010

  • Dental coating, tooth-desensitizing
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