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510(k) Data Aggregation

    K Number
    K080228
    Device Name
    ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
    Manufacturer
    NOVAMIN TECHNOLOGY, INC.
    Date Cleared
    2008-03-27

    (57 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAMIN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oralief™ OTC Toothpaste for Sensitive Teeth is a fluoride-free daily use cleaning toothpaste that provides rapid and continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of the occlusion of dentin tubules
    Device Description
    Oralief™ OTC Toothpaste for Sensitive Teeth is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® (calcium sodium phosphosilicate) as its active ingredient. The non-aqueous formulation is designed to clean teeth as well as to physically occlude dentin tubules for the reduction of tooth sensitivity. When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
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    K Number
    K071267
    Device Name
    PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN
    Manufacturer
    NOVAMIN TECHNOLOGY, INC.
    Date Cleared
    2007-05-18

    (11 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAMIN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PerioSRP™ Tooth Root Conditioner with NovaMin® is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that PerioSRP™ Tooth Root Conditioner with NovaMin® is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.
    Device Description
    Not Found
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    K Number
    K061359
    Device Name
    DENSHIELD TREATMENT FOR SENSITIVE TEETH
    Manufacturer
    NOVAMIN TECHNOLOGY, INC.
    Date Cleared
    2006-10-18

    (155 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAMIN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DenShield™ is intended for the rapid and continual relief of hypersensitivity associated with exposed tooth dentin. Studies have shown that Dentibitly is effective at occluding exposed dentinal tubules, which has been showmin the literature to be associated with a reduction in hypersensitivity.
    Device Description
    Not Found
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    K Number
    K040858
    Device Name
    ORALIEF THERAPY FOR SENSITIVE TEETH
    Manufacturer
    NOVAMIN TECHNOLOGY, INC.
    Date Cleared
    2004-09-02

    (153 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAMIN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provides rapid and continual relief from tooth hypersensitivity-dueto cold, heat, acids, sweets, or contact through its action of the occlusion of dentin tubules.
    Device Description
    Oralief™ Therapy for Sensitive Teeth incorporates NovaMin® as its active ingredient. The unique brushing regimen and NovaMin® -containing formulation provide rapid and continual relief from tooth sensitivity. NovaMin® (calcium sodium phosphosilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® rapidly releases mineral-building ions, allowing it to relieve from sensitivity by physically occluding dentin tubules. Within a short period of time, essentially all of the NovaMin® reacts to form a mineral layer which is chemically and structurally similar to natural tooth mineral.
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    K Number
    K041371
    Device Name
    BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN
    Manufacturer
    NOVAMIN TECHNOLOGY, INC.
    Date Cleared
    2004-08-23

    (91 days)

    Product Code
    EJR
    Regulation Number
    872.6030
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAMIN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Butler NuCare™ Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. Secondarily, Butler NuCare™ Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity, post-scaling and root planing.
    Device Description
    Butler NuCare™ Prophylaxis Paste with NovaMin® is a product that is intended for cleaning and polishing procedures as a part of a professionally administered dental prophylaxis treatment. Butler NuCare™ Prophylaxis Paste with NovaMin® is also designed to physically occlude dentinal tubules for the immediate relief of tooth sensitivity, post-scaling and root planing. NovaMin® (calcium sodium phosphosilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
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    K Number
    K040473
    Device Name
    ORAVIVE TOOTH REVITALIZING PASTE
    Manufacturer
    NOVAMIN TECHNOLOGY, INC.
    Date Cleared
    2004-03-10

    (15 days)

    Product Code
    LBH, NRE
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAMIN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oravive™ is a fluoride-free toothpaste product intended for cleaning the tooth surface on a daily basis. Clinical studies have shown that Oravive™ also provides relief from tooth sensitivity due to cold, heat, acids, sweets, or contact by the occlusion of dentin tubules.
    Device Description
    Oravive™ is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® as its active ingredient. The non-aqueous formulation is designed to clean your teeth as well as give your whole mouth a fresh feeling we call REVITALIZING! Oravive™ is also designed to physically occlude dentin tubules for the management of sensitive teeth. NovaMin® (calcium sodium phosphossilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aquoous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
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    K Number
    K033295
    Device Name
    BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN
    Manufacturer
    NOVAMIN TECHNOLOGY, INC.
    Date Cleared
    2003-10-28

    (14 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAMIN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Butler Nucare® Root Conditioner with NovaMin® is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that Butler Nucare® Root Conditioner with NovaMin® is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.
    Device Description
    Butler Nucare® Root Conditioner with NovaMin® is a biologically-compatible device designed to condition exposed tooth roots and to physically occlude dentin tubules for the management of sensitive teeth. Butler Nucare Root Conditioner with NovaMin® is an aqueous suspension of an inorganic particulate, NovaMin® (calcium sodium phosphosilicate), composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically adhere to exposed root dentin and to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
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