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510(k) Data Aggregation

    K Number
    K121318
    Device Name
    PROSOFT
    Manufacturer
    PERMA LABORATORIES
    Date Cleared
    2012-06-06

    (35 days)

    Product Code
    EBP
    Regulation Number
    872.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERMA LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An over the counter temporary Denture Reliner, intended to replace a worn denture lining.
    Device Description
    ProSoft™ is an over the counter temporary Denture Reliner kit. The device contains a Polyethyl Methacrylate powder, a liquid Ethyl Alcohol, and a mixing stick. The material contains no Methyl Methacrylate Monomer, no Phtalate Plasticizer, no Bisphenol A, and no Cadmium colors. The powder and the liquid are to be mixed together with the mixing stick to make the relining material. The relining material is then poured into the denture base and placed into the mouth to make the impression. Once the impression has cured any excess material is trimmed with a sharp knife. Can be easily removed with warm water or soaking in a solution of hydrogen peroxide and water overnight.
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