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510(k) Data Aggregation

    K Number
    K241924
    Device Name
    Elastic Impression Material
    Manufacturer
    Beijing OKVD Biological Technology Ltd.
    Date Cleared
    2024-12-27

    (179 days)

    Product Code
    ELW
    Regulation Number
    872.3660
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    Applicant Name (Manufacturer) :

    Beijing OKVD Biological Technology Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.
    Device Description
    The product is a kind of addition-cure silicon rubber impression material composed of vinyl polysiloxane and various fillers with neutral smell and applicable to impression in dentistry. This product is mainly composed of a matrix and a catalyst. The matrix is mainly composed of polydimethylsiloxane, vinyl silicone oil, methyl hydrogen polysiloxane, silica dioxide, ,calcium carbonate, and colorants. The catalyst is mainly composed of polydimethylsiloxane, silica dioxide, calcium carbonate, platinum catalyst, and colorants.
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