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

  • 00850362007052 ()

  • Total Volume: 10 Milliliter
10-1010

  • Dental coating, tooth-desensitizing
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
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
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
FluoriMax 2.5% NaF FMFT demo pack
ELEVATE ORAL CARE, LLC
630FMFT00
In Commercial Distribution

  • 00858290006307 ()


  • Dental coating, tooth-desensitizing
FluoriMax 2.5% NaF Varnish Flow Through Salted Caramel Foil Pk
ELEVATE ORAL CARE, LLC
530CMV118
In Commercial Distribution

  • 00858290006222 ()
  • 00858290006239 ()


  • Dental coating, tooth-desensitizing
FluoriMax 2.5% NaF Varnish Flow Through BG Foil Pk
ELEVATE ORAL CARE, LLC
530BGV101
In Commercial Distribution

  • 00858290006154 ()


  • Dental coating, tooth-desensitizing
FluoriMax 2.5% NaF Varnish Through Mint Ampoule
ELEVATE ORAL CARE, LLC
530MTV110
In Commercial Distribution

  • 00858290006147 ()


  • Dental coating, tooth-desensitizing
Advantage Arrest Silver Diamine Fluoride 38% Unit Dose Ampoule with applicators 30pk
ELEVATE ORAL CARE, LLC
Ampoule
In Commercial Distribution

  • 00858290006130 ()
  • 00858290006161 ()

  • Total Volume: 0.1 Milliliter


  • Dental coating, tooth-desensitizing
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