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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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Dentin Desensitizer with Fluoride - 00865849000242

A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
10 ml
Not in Commercial Distribution

  • 00865849000242 ()

  • Total Volume: 10 Milliliter
9515140

  • Dental coating, tooth-desensitizing

DDS Dentin Desensitizer System with Fluoride - 00865849000211

A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
G6
Not in Commercial Distribution

  • 00865849000211 ()

  • Total Volume: 5 Milliliter


  • Dental coating, tooth-desensitizing

Dentin Desensitizing with Fluoride - 00865849000204

A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
DDS
Not in Commercial Distribution

  • 00865849000204 ()


  • Dental coating, tooth-desensitizing

Burkhart Varnish 5% Naf Creme Brulee 0.4mL (50) - 00854212006790

No Description
BURKHART DENTAL SUPPLY CO., THE
72722204
In Commercial Distribution

  • 00854212006790 ()
  • 00854212006837 ()


  • Dental coating, tooth-desensitizing

Burkhart Varnish 5% NaF Mint 0.4mL (50) - 00854212006783

No Description
BURKHART DENTAL SUPPLY CO., THE
72722203
In Commercial Distribution

  • 00854212006783 ()
  • 00854212006820 ()


  • Dental coating, tooth-desensitizing

Burkhart Varnish 5% Naf Cherry 0.4mL (50) - 00854212006776

No Description
BURKHART DENTAL SUPPLY CO., THE
72722202
In Commercial Distribution

  • 00854212006776 ()
  • 00854212006813 ()


  • Dental coating, tooth-desensitizing

Burkhart Varnish 5% NaF Melon 0.4mL (50) - 00854212006769

No Description
BURKHART DENTAL SUPPLY CO., THE
72722201
In Commercial Distribution

  • 00854212006769 ()
  • 00854212006806 ()


  • 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
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