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510(k) Data Aggregation

    K Number
    K010069
    Device Name
    DURABOND NON-PRECIOUS CERAMIC ALLOY
    Manufacturer
    MATECH, INC.
    Date Cleared
    2001-02-15

    (38 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    MATECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K993572
    Device Name
    CERADIUM V NON-PRECIOUS CERAMIC ALLOY
    Manufacturer
    MATECH, INC.
    Date Cleared
    1999-12-13

    (53 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    MATECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - Identification: A base metal alloy is a device composed of a material such as a Amixture of Nickel and Chromium - Intended Use: This material is to be used by the dentist in the fabrication of Ba custom-made dental device, such as a porcelain veneer for a tooth. - Classifcation: Class II C-
    Device Description
    Ceradium V Non-Precious Ceramic Alloy
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    K Number
    K992881
    Device Name
    HI BOND NON-PRECIOUS CERAMIC ALLOY
    Manufacturer
    MATECH, INC.
    Date Cleared
    1999-11-19

    (85 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    MATECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - Identification: A base metal alloy is a device composed of a material such as a mixture of Nickel and Chromium - Intended Use: This material is to be used by the dentist in the fabrication of a custom-made dental device, such as a porcelain veneer for a tooth. - Classification: Class II
    Device Description
    Hi Bond Non-Precious Ceramic Alloy is a base metal alloy composed of a material such as a mixture of Nickel and Chromium.
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    K Number
    K992705
    Device Name
    CERADIUM NON-PRECIOUS CERAMIC ALLOY
    Manufacturer
    MATECH, INC.
    Date Cleared
    1999-09-22

    (42 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    MATECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Not Found
    Device Description
    Not Found
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    K Number
    K974894
    Device Name
    KROMATICA COLOR CHANGING ALGINATE
    Manufacturer
    MATECH, INC.
    Date Cleared
    1998-02-12

    (43 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    MATECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Intended Use: This material is to be used by the dentist to produce an impression of a person's mouth/teeth and then a plaster material is poured into this impression to create a cast of the patient's mouth/ teeth.
    Device Description
    Kromatica Color Changing Alginate
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