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

    CERAPALL 6

    K Number: K911669 · Decision Aug 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    193
    Applicant Total
    67
    Review Days
    127

    Basic Information

    Device Name
    CERAPALL 6
    K Number
    K911669
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    METALOR DENTAL USA CORP.
    Date Received
    April 11, 1991
    Decision Date
    August 16, 1991
    Product Code
    EJS
    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
    EJS Alloy, Other Noble Metal

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