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Found 13 results

510(k) Data Aggregation

    K Number
    K111383
    Device Name
    ZIRPRIME
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    2011-08-12

    (87 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORITAKE CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zirprime is intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations.
    Device Description
    Not Found
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    K Number
    K111107
    Device Name
    SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    2011-06-30

    (71 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORITAKE CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in prosthetic dentistry to create the porcelain exterior on a porcelain fused to metal (PFM) dental prosthesis.
    Device Description
    Not Found
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    K Number
    K052304
    Device Name
    SUPER PORCELAIN EX-3 PRESS
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    2005-11-23

    (91 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORITAKE CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in prosthetic dentistry to create the porcelain exterior on a porcelain fused to metal (PFM) dental prosthesis by using ceramic press technique.
    Device Description
    Not Found
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    K Number
    K050920
    Device Name
    CZR PRESS LF STAINS
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    2005-05-11

    (29 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORITAKE CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in replicating shade variations found in natural teeth For use in replicating Shade Variations using CZR Press LF porcelain.
    Device Description
    Not Found
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    K Number
    K050160
    Device Name
    KATANA ZIRCONIA
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    2005-02-07

    (13 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORITAKE CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KATANA Zirconia is intended for CAD/CAM fabrication of zirconia frameworks for allceramic dental restorations.
    Device Description
    Not Found
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    K Number
    K043462
    Device Name
    CZR PRESS LF
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    2005-01-11

    (27 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORITAKE CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in prosthetic dentistry to create an all-ceramic prosthesis
    Device Description
    Not Found
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    K Number
    K031968
    Device Name
    CERABIEN ZR
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    2003-12-22

    (179 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORITAKE CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in prosthetic dentistry to create an all-ceramic prosthesis
    Device Description
    Not Found
    Ask a Question
    K Number
    K033049
    Device Name
    CZR PRESS
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    2003-10-24

    (25 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORITAKE CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in prosthetic dentistry to create an all-ceramic prosthesis
    Device Description
    Not Found
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    K Number
    K992023
    Device Name
    GRAND CERAM
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    1999-09-03

    (79 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORITAKE CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in prosthetic dentistry to create an all-ceramic prosthesis.
    Device Description
    Not Found
    Ask a Question
    K Number
    K992024
    Device Name
    SUPER PORCELAIN TI-22
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    1999-08-27

    (72 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORITAKE CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in prosthetic dentistry to create a porcelain prosthesis on a frame of titanium.
    Device Description
    Super Porcelain TI-22 and Accessories
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