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

    JEL-20

    K Number: K012303 · Decision Aug 22, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    193
    Applicant Total
    55
    Review Days
    33

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    Basic Information

    Device Name
    JEL-20
    K Number
    K012303
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    J.F. Jelenko & Co., Inc.
    Date Received
    July 20, 2001
    Decision Date
    August 22, 2001
    Product Code
    EJS
    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
    EJS Alloy, Other Noble Metal

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    Other Clearances by J.F. Jelenko & Co., Inc.

    K Number Device Name
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    K001260 ALLROUND 55 LF
    K001196 JEL BIOS 90 (CODE NAME RD-2401)
    K000532 JEL 15
    K993136 JEL BIOS 10 (CODE NAME RD-1801)
    K993152 JEL BIOS 18 (CODE NAME RD- 1214)
    K991564 JELTEMP
    Search all 55 clearances from J.F. Jelenko & Co., Inc. →