BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MASKY

    K Number: K973542 · Decision Feb 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    2
    Review Days
    145

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    Basic Information

    Device Name
    MASKY
    K Number
    K973542
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pressing DI Monticelli Rag. Stefano
    Date Received
    September 18, 1997
    Decision Date
    February 10, 1998
    Product Code
    EBI
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EBI Resin, Denture, Relining, Repairing, Rebasing

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    Other Clearances by Pressing DI Monticelli Rag. Stefano

    K Number Device Name
    K955946 ACETAL DENTAL/PREFORMED CLASP