BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇿🇦 South Africa

    AURENORM 68

    K Number: K972945 · Decision Nov 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    193
    Applicant Total
    19
    Review Days
    159

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    AURENORM 68
    K Number
    K972945
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aurex Precious Metal Industries (Pty)Ltd
    Date Received
    June 20, 1997
    Decision Date
    November 26, 1997
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EJS), ordered by most recent decision date.

    BRIGHT GOLD XH

    FDA 510(k)
    FDA Class 2 ·Dental

    SIMIDUR SUPERIOR

    FDA 510(k)
    FDA Class 2 ·Dental

    STERNGOLD 1, MODEL 1127781

    FDA 510(k)
    FDA Class 2 ·Dental

    ECO E4

    FDA 510(k)
    FDA Class 2 ·Dental

    STERNGOLD 66, MODEL #1180230

    FDA 510(k)
    FDA Class 2 ·Dental

    SIMIDUR S1S

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Aurex Precious Metal Industries (Pty)Ltd

    K Number Device Name
    K972946 AURELUX 77
    K972949 AURELUX BIO Y85PF
    K972943 AURECAST 92
    K972953 PALAUREX 76KF
    K972951 HIPALLAUR 51
    K972956 PALCERAM 82SF
    K972955 PALCERAM 56
    K972954 PALAUREX 78
    K972950 HIPALLAUR 19
    K972952 AUREBOND 51
    Search all 19 clearances from Aurex Precious Metal Industries (Pty)Ltd →