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510(k) Data Aggregation

    K Number
    K221668
    Device Name
    Dental Impression Material
    Manufacturer
    Chemoment Materials Co.,ltd
    Date Cleared
    2022-08-08

    (61 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chemoment Materials Co.,ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dental Impression Material is intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient's teeth and gums.
    Device Description
    The Dental Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry. The Dental Impression Material is very easy to mix and has good dimensional stability which helps to make precise impression taking.
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