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

  • 00883205102652 ()
5743

  • Dental coating, tooth-desensitizing
Enamelast Unit Dose 5pk - Walterberry
ULTRADENT PRODUCTS, INC.
4526
In Commercial Distribution

  • 00883205101754 ()
4526

  • 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
10 ml
Not in Commercial Distribution

  • 00865849000228 ()

  • 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
WALG SELFGRIP SELF-ADHER BNDG 3
WALGREEN CO.
912087
In Commercial Distribution

  • 00311917179100 ()
  • 10311917179107 ()


  • Pressure bandage, Hevea-latex, single-use, non-sterile
WALG SELF GRIP TAPE 2X70
WALGREEN CO.
912085
In Commercial Distribution

  • 00311917179094 ()
  • 10311917179091 ()


  • Pressure bandage, Hevea-latex, single-use, non-sterile
Acclean Fluoride Varnish
HENRY SCHEIN, INC.
1127170
In Commercial Distribution

  • 10304040002718 ()
  • 00304040002711 ()
  • 20304040002715 ()
1127170

  • Dental coating, tooth-desensitizing
Acclean Fluoride Varnish
HENRY SCHEIN, INC.
1127169
In Commercial Distribution

  • 10304040002701 ()
  • 00304040002704 ()
  • 20304040002708 ()
1127169

  • Dental coating, tooth-desensitizing
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