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

    OPTODENT/OPTOGNATH

    K Number: K936058 · Decision May 16, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    54
    Applicant Total
    1
    Review Days
    147

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    Basic Information

    Device Name
    OPTODENT/OPTOGNATH
    K Number
    K936058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3590
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectrum Healthcare Group
    Date Received
    December 20, 1993
    Decision Date
    May 16, 1994
    Product Code
    ELM
    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
    ELM Denture, Plastic, Teeth

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