BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACETAL DENTAL/PREFORMED CLASP

    K Number: K954971 · Decision Dec 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    45

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    Basic Information

    Device Name
    ACETAL DENTAL/PREFORMED CLASP
    K Number
    K954971
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3285
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B & H Technical Services , Ltd.
    Date Received
    October 27, 1995
    Decision Date
    December 11, 1995
    Product Code
    EHP
    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
    EHP Clasp, Preformed

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