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510(k) Data Aggregation

    K Number
    K252035
    Device Name
    DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)
    Manufacturer
    Kamemizu Chemical Industry Co., Ltd
    Date Cleared
    2025-09-17

    (79 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K070698
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is a soft acrylic resin used to line the denture base. It is a tissue conditioner. By lining the mucous membrane side of dentures, it is used for temporary relining, tissue conditioning, and obtaining functional impressions.

    Device Description

    DENTURE SOFT EX is a soft lining material for removable dentures.
    It is a soft acrylic resin used to line the denture base. It is a tissue conditioner. By lining the mucous membrane side of dentures, it is used for temporary relining, tissue conditioning, and obtaining functional impressions.
    The device consists of powder and liquid. The powder contains acrylic polymer (POLY (ETHYL METHACRYLATE)) and others. The liquid contains plasticizer, ethanol and others.
    The powder and liquid are mixed when it is used and starts gelation, forms soft acrylic resin.

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