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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    Centrix Inc

    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
    K200764
    Device Name
    STATSTIX
    Manufacturer
    Centrix Incorporated
    Date Cleared
    2020-10-15

    (205 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Centrix Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    StatStix is applied to control temporary bleeding caused by minor cuts and abrasions that may occur on gingival tissue during dental procedures.
    Device Description
    StatStix is designed incorporating a hand-held polypropylene handle with a nylon polyamide applicator tip coated with a dried solution of 25% Aluminum Sulfate Hydrate Solution with Mint Flavor. The device is configured in two sizes to help control minor gingival bleeding intended for transient use by a dentist during dental restorative procedures.
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