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

    MYERSON IR DENTURE BASE

    K Number: K954810 · Decision Nov 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    10
    Review Days
    41

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    Basic Information

    Device Name
    MYERSON IR DENTURE BASE
    K Number
    K954810
    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
    October 19, 1995
    Decision Date
    November 29, 1995
    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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    Other Clearances by Austenal, Inc.

    K Number Device Name
    K011674 DC - CRISTAL
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    K001815 DC ZIRKON
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    K970522 MYERSON'S ECONOMY DENTURE BASE MATERIAL
    K970205 VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY
    K955509 MIDAS GOLD ELECTROFORMING SYSTEM
    K933468 MYERSON'S PERMASOFT SOFT RELINE MATERIAL
    K924526 DENTURE PLASTIC TEETH