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

    JELDENT MULTICRYL

    K Number: K990056 · Decision Mar 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    167
    Registration Numbers
    167
    Same Product Code
    322
    Applicant Total
    55
    Review Days
    77

    Basic Information

    Device Name
    JELDENT MULTICRYL
    K Number
    K990056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    J.F. JELENKO & CO., INC.
    Date Received
    January 7, 1999
    Decision Date
    March 25, 1999
    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 J.F. JELENKO & CO., INC.

    K Number Device Name
    K012303 JEL-20
    K002993 HERACERAM
    K002645 JEL BIOS PURE
    K002222 RD-2104
    K001360 SIGNUM
    K001260 ALLROUND 55 LF
    K001196 JEL BIOS 90 (CODE NAME RD-2401)
    K000532 JEL 15
    K993152 JEL BIOS 18 (CODE NAME RD- 1214)
    K993136 JEL BIOS 10 (CODE NAME RD-1801)
    Search all 55 clearances from J.F. JELENKO & CO., INC. →