BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    OMNI-MATRIX

    K Number: K930151 · Decision Sep 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    254

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    Basic Information

    Device Name
    OMNI-MATRIX
    K Number
    K930151
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innovative Technology , Ltd.
    Date Received
    January 12, 1993
    Decision Date
    September 23, 1993
    Product Code
    JEP
    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
    JEP Retainer, Matrix

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