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

    JEWEL CAST III

    K Number: K003037 · Decision Dec 5, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    152
    Applicant Total
    78
    Review Days
    67

    Basic Information

    Device Name
    JEWEL CAST III
    K Number
    K003037
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3710
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    JENERIC/PENTRON, INC.
    Date Received
    September 29, 2000
    Decision Date
    December 5, 2000
    Product Code
    EJH
    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
    EJH Alloy, Metal, Base

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