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510(k) Data Aggregation

    K Number
    K213175
    Device Name
    No Stress Impress
    Manufacturer
    No Stress Impress LLC
    Date Cleared
    2023-01-19

    (478 days)

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

    No Stress Impress LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    No Stress Impress is intended for use as a rebasing and relining impression material as well as for general impressions including but not limited to dentures, root surfaces, and posts.
    Device Description
    No Stress Impress is a thermoplastic impression material available for full or partial impressions that comes as a stick or wafer.
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