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510(k) Data Aggregation

    K Number
    K972946
    Device Name
    AURELUX 77
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-12-19

    (182 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
    Device Description
    High gold casting alloy
    Ask a Question
    K Number
    K972945
    Device Name
    AURENORM 68
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-11-26

    (159 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Casting alloy used for fabrication of metallo-ceramic restorations in conjunction with dental ceramics of thermal expansion co-efficient not less than 16.3 x 10 -9K. (25 - 600°C)
    Device Description
    High gold casting alloy
    Ask a Question
    K Number
    K972949
    Device Name
    AURELUX BIO Y85PF
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-09-18

    (90 days)

    Product Code
    EJT, EJS
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
    Device Description
    High gold casting alloy
    Ask a Question
    K Number
    K972943
    Device Name
    AURECAST 92
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-09-16

    (88 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental casting alloy for making restoration.
    Device Description
    High gold casting alloy
    Ask a Question
    K Number
    K972950
    Device Name
    HIPALLAUR 19
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-09-05

    (77 days)

    Product Code
    EJT, DAT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
    Device Description
    Gold reduced palladium based casting alloy
    Ask a Question
    K Number
    K972951
    Device Name
    HIPALLAUR 51
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-09-05

    (77 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
    Device Description
    Medium gold palladium based casting alloy
    Ask a Question
    K Number
    K972952
    Device Name
    AUREBOND 51
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-09-05

    (77 days)

    Product Code
    EJT, DAT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
    Device Description
    Medium gold casting alloy
    Ask a Question
    K Number
    K972953
    Device Name
    PALAUREX 76KF
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-09-05

    (77 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
    Device Description
    Low gold palladium based casting alloy
    Ask a Question
    K Number
    K972954
    Device Name
    PALAUREX 78
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-09-05

    (77 days)

    Product Code
    EJT, DAT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
    Device Description
    Low gold palladium based casting alloy
    Ask a Question
    K Number
    K972955
    Device Name
    PALCERAM 56
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-09-05

    (77 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
    Device Description
    Palladium silver based casting alloy
    Ask a Question

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