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510(k) Data Aggregation

    K Number
    K250222
    Device Name
    SDF Pro
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2025-05-07

    (100 days)

    Product Code
    PHR
    Regulation Number
    872.3260
    Why did this record match?
    Product Code :

    PHR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SDF Pro is intended to be used by dental professionals to treat tooth hypersensitivity. For use in adults over the age of 21.
    Device Description
    Not Found
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    K Number
    K241041
    Device Name
    Silver Fluoride Hypersensitivity Varnish
    Manufacturer
    Young Dental Manufacturing Co. 1, LLC
    Date Cleared
    2025-02-28

    (318 days)

    Product Code
    PHR
    Regulation Number
    872.3260
    Why did this record match?
    Product Code :

    PHR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Young Silver Fluoride Hypersensitivity Varnish is indicated for the treatment of dental hypersensitivity in adults. It is intended for professional use only.
    Device Description
    Young Silver Fluoride Hypersensitivity Varnish is a formulation of silver, sodium fluoride, chitosan, acetic acid, and purified water intended for the treatment of dental hypersensitivity in adults. It is intended for professional use only. Like other 510(k) cleared dental hypersensitivity varnishes including the predicate device, the proposed device works by physically occluding dentinal tubules through its silver and fluoride components. It contains small silver particles to facilitate their entry into the dentinal tubules, as well as chitosan and acetic acid to evenly disperse the solution. The product is supplied in a 10mL bottle with a dropper dispensing tip. One to two drops of the varnish can treat up to 8 sites. If needed, a second application of the varnish may be administered after 1 week.
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    K Number
    K240059
    Device Name
    FAgamin®
    Manufacturer
    Tedequim SRL
    Date Cleared
    2024-05-16

    (129 days)

    Product Code
    PHR
    Regulation Number
    872.3260
    Why did this record match?
    Product Code :

    PHR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Treatment of dentinal hypersensitivity. For use in adults over the age of 21.
    Device Description
    FAgamin® is a professional treatment for dentin hypersensitivity. It is indicated for adults over 21 years of age. FAgamin® is presented in a 5 ml black dropper bottle and contains a 38% w/v solution of diamine silver fluoride. Its design includes a secure screw cap and labeled container.
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    K Number
    K240619
    Device Name
    e-SDF
    Manufacturer
    Kids-e-Dental LLP
    Date Cleared
    2024-03-06

    (1 days)

    Product Code
    PHR
    Regulation Number
    872.3260
    Why did this record match?
    Product Code :

    PHR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Treatment of dentinal hypersensitivity For use in adults over the age of 21.
    Device Description
    e-SDF is a single component liquid device made up of 38% silver diamine fluoride.Silver diamine fluoride solution is applied to the tooth, to reduce tooth sensitivity by physically occluding the open dentinal tubules. e-SDF is a liquid that is applied to the teeth using an applicator brush or similar application.
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    K Number
    K222459
    Device Name
    Centrix FluoroSilver Silver Diamine Fluoride 38%
    Manufacturer
    Centrix Inc
    Date Cleared
    2023-10-27

    (438 days)

    Product Code
    PHR
    Regulation Number
    872.3260
    Why did this record match?
    Product Code :

    PHR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Treatment of Dental Hypersensitivity for use in adults over the age of 21.
    Device Description
    The Centrix FluoroSilver is a professional tooth desensitizer that is composed of Aqueous Silver Diamine Fluoride, 38.3% to 43.2% w/v. The solution is composed of water, ammonia, fluoride, silver and a colorant. The device is provided in a single 5 ml squeezable dropper bottle or a multi-pack which includes three 5 ml squeezable dropper bottles. Each variation is packaged in a preformed trav and includes applicators and the Instructions for Use (IFU). The primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules by the formation of a precipitate.
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    K Number
    K222323
    Device Name
    Black Diamond
    Manufacturer
    Elevate Oral Care, LLC
    Date Cleared
    2023-06-23

    (325 days)

    Product Code
    PHR
    Regulation Number
    872.3260
    Why did this record match?
    Product Code :

    PHR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Black Diamond is intended as Treatment of Dental Hypersensitivity. For use in adults over the age of 21.
    Device Description
    Black Diamond is a two-part liquid intended as a treatment for dentin hypersensitivity, for use in adults over the age of 21. The product does not need light cured and will provide occlusion of dentinal tubules preventing or reducing dentin hypersensitivity. The formula has two liquid steps, each provided in an individual dropper bottle. A drop of each product is placed in a mixing well/dappen dish and applied sequentially to the tooth using a standard flock tip applicator bush such as a microbrush. The mixing pad, and applicator may or may not be included in the product package. These are standard items in dental offices and numerous types of each will work.
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    K Number
    K172047
    Device Name
    Riva Star
    Manufacturer
    SDI Limited
    Date Cleared
    2018-04-11

    (279 days)

    Product Code
    PHR
    Regulation Number
    872.3260
    Why did this record match?
    Product Code :

    PHR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Treatment of dentinal hypersensitivity. For use in adults over the age of 21.
    Device Description
    Riva Star is a two-component device made up of Riva Star Step 1, containing silver diamine fluoride liquid, and Riva Star Step 2, containing aqueous potassium iodide liquid. Riva Star Step 1 silver diamine fluoride solution is applied to the tooth, immediately followed by Riva Star Step 2 aqueous potassium iodide, which forms an immediate reaction precipitate of silver iodide, thereby reducing tooth sensitivity by physically occluding the open dentinal tubules. Riva Star as well as predicates are liquids or gels that are applied to the teeth using an applicator brush or similar application.
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    K Number
    K102973
    Device Name
    SILVER DENTAL ARREST
    Manufacturer
    COOLEY CONSULTING, INC.
    Date Cleared
    2014-07-31

    (1394 days)

    Product Code
    PHR
    Regulation Number
    872.3260
    Why did this record match?
    Product Code :

    PHR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Treatment of Dental Hypersensitivity. For use in adults over the age of 21.
    Device Description
    Not Found
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