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

    MYERSON'S PERMASOFT SOFT RELINE MATERIAL

    K Number: K933468 · Decision Jan 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    10
    Review Days
    173

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    Basic Information

    Device Name
    MYERSON'S PERMASOFT SOFT RELINE MATERIAL
    K Number
    K933468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Austenal, Inc.
    Date Received
    July 16, 1993
    Decision Date
    January 5, 1994
    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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