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510(k) Data Aggregation

    K Number
    K052463
    Device Name
    PROMETAL HN86
    Manufacturer
    PROMETAL TECHNOLOGIES
    Date Cleared
    2005-10-14

    (36 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HIGH NOBLE DENTAL ALLOY FOR THE FABRICATION OF SINGLE CROWNS, BRIDGES, INLAYS AND ONLAYS.
    Device Description
    Not Found
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    K Number
    K041378
    Device Name
    BIO 60
    Manufacturer
    KODENT, INC.
    Date Cleared
    2004-08-02

    (70 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIO 60 is intended for use in the fabrication of implant superstructures and gold cylinders for dental implants.
    Device Description
    Gold cylinder for using UCLA Abutment
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    K Number
    K040672
    Device Name
    PORTA REFLEX
    Manufacturer
    WIELAND DENTAL + TECHNIK GMBH & CO. KG
    Date Cleared
    2004-05-27

    (73 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Porta Reflex is a gold-platinum alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/ Onlays, Partial crowns, Crowns, Short span bridges, Long span bridges, Removable partials and can be used for Telescopic and milling work. Porta Reflex can be veneered with suitable dental ceramics as well as with dental-composites.
    Device Description
    Porta Reflex is an extra-hard gold-platinum ceramic alloy with high contents of noble metals (97,7%), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and crowns, up to long span bridges with two or more pontics and removable partials. It is free of copper and therefore suitable for telescopic and milling work. Porta Reflex is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Porta Reflex can be veneered with suitable dental ceramics and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.
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    K Number
    K040524
    Device Name
    PORTA SOLDER 1090 W
    Manufacturer
    WIELAND DENTAL + TECHNIK GMBH & CO. KG
    Date Cleared
    2004-05-20

    (80 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Porta Solder 1090 W is intended for use as a solder before firing in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration. It should be used only together with recommended dental alloys with suitable melting ranges and compositions
    Device Description
    Porta Solder 1090 W is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a white alloy with high contents of precious metals (Gold, Palladium, Iridium and Silver: 95,5%). Porta Solder 1090 W is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges. It is intended as solder before firing for ceramic dental alloys with appropriate melting ranges and compositions, especially Euro 50, which is manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta Solder 1090 W is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
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    K Number
    K040043
    Device Name
    NDX-40 ALLOY
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2004-03-03

    (51 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ¾ and single crowns, inlays, veneer crowns and short span bridges.
    Device Description
    Not Found
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    K Number
    K034049
    Device Name
    HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM
    Manufacturer
    HERAEUS KULZER GMBH
    Date Cleared
    2004-03-01

    (62 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reconstruction of porcelain to metal dental restorations/reconstruction of dental restorations.
    Device Description
    Not Found
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    K Number
    K033279
    Device Name
    GOLD DENTAL CASTING ALLOYS
    Manufacturer
    BEGO U.S.A.
    Date Cleared
    2004-01-15

    (97 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BegoStar is a precious dental casting alloy to make metal fused to ceramic dental restorations Pontorex G is a precious dental casting alloy to make crown and bridge dental restorations Platinlloyd KF is a precious dental casting alloy to make metal fused to ceramic dental restorations Bio Platinilloyd is a precious dental casung alloy to make metal fused to ceramic dental restorations Begopal S is a precious dental casting alloy to make metal fused to ceramic dental restorations Begorex 45 is a precious dental casting alloy to make metal fused to ccramic dental restorations PontoStar Ti is a precious dental casting alloy to make metal fused to ceramic dental restorations Pontolloyd G is a precious dental casting alloy to make metal fused to ceramic dental restorations Bio Pontostar XL is a precious dental casting alloy to make metal fused to ceramic dental restorations Begolloyd 60 is a precious dental casting alloy to make crown and bridge dental restorations Begolloyd PF is a precious dental casting alloy to make crown and bridge dental restorations PontoStar G is a precious dental casting alloy to make metal fused to ceramic dental restorations Gold EWL H is a precious dental casting alloy to make crown and bridge dental restorations Platinlloyd M is a precious dental casting alloy to make crown and bridge dental restorations Begopal 300 is a precious dental casting alloy to make metal fused to ceramic dental restorations Begostar LFC is a precious dental casting alloy to make metal fused to ceramic dental restorations
    Device Description
    Gold Dental Casting Alloys
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    K Number
    K033446
    Device Name
    APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82
    Manufacturer
    WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
    Date Cleared
    2003-11-13

    (15 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reconstruction of porcelain-to-metal dental restorations.
    Device Description
    Apex 93, Apex87, Apex85, Apex77, e-Sarang 88 and e-Sarang 82 are dental gold alloys for the fabrication of Porcelain-Fused-to-Metal Crowns, Bridges, and implant-supported prosthesis substructures.
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    K Number
    K033435
    Device Name
    E-SARANG 86, DM78, DM55
    Manufacturer
    WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
    Date Cleared
    2003-11-12

    (15 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reconstruction of dental restorations. e-Sarang 86: Inlays for non stress-bearing areas. DM-78: full crowns, 3/4 crowns, and short-span fixed partial dentures. DM-55: full crowns, long-span fixed partial dentures, and removable partial dentures
    Device Description
    e-Sarang 86, DM-78 and DM-55 are dental casting gold alloy for the fabrication of inlay/onlays, crowns, short span bridges, long span bridges and removable partials.
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    K Number
    K032320
    Device Name
    APPOLLO 3 ALLOY
    Manufacturer
    DENTSPLY INTERNATIONAL
    Date Cleared
    2003-10-01

    (65 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fabricating inlays, crowns and small span bridges.
    Device Description
    APOLLO 3 ALLOY is a yellow, high noble, gold-based dental alloy.
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