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510(k) Data Aggregation

    K Number
    K020347
    Device Name
    AGC SPEZIALLEGIERUNG
    Date Cleared
    2002-04-24

    (79 days)

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

    **WIELAND EDELMETALLE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AGC Speziallegierung is a gold-platinum ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/Onlays, Crowns, Short span bridges, Long span bridges, Pontics for AGC bridges, Removable partials and can be used for Telescopic and milling work. AGC Speziallegierung can be veneered with suitable dental ceramics as well as with dental-composites.
    Device Description
    AGC Speziallegierung is a gold-platinum ceramic alloy with a high content of noble metals (97,5%), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and single crowns up to long span bridges with two or more pontics and pontics for AGC bridges. In addition, it can be used for manufacturing removable partials. It is free of copper and suitable for telescopic and milling work. AGC Speziallegierung 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. AGC Speziallegierung 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
    K012839
    Device Name
    AUROPAL, ORDER-NO.: 2101
    Date Cleared
    2001-12-31

    (130 days)

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

    **WIELAND EDELMETALLE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Auropal 1 is a gold-silver casting 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
    Device Description
    Auropal 1 is an extra-hard gold-silver casting alloy (67% noble metals), 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 to removable partials. In addition, it is suitable for telescopic and milling work. Auropal 1 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
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    K Number
    K012841
    Device Name
    DUO PAL 6, ORDER-NO.: 2154
    Date Cleared
    2001-11-20

    (89 days)

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

    **WIELAND EDELMETALLE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Duo Pal 6 is a palladium-gold ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Crowns, Short span bridges, Long span bridges, Removable partials and can be used for - Telescopic and milling work. Duo Pal 6 can be veneered with suitable dental ceramics as well as with dental composites.
    Device Description
    Duo Pal 6 is a dental alloy with high contents of noble metals (81,5%) intended for dental technicians to fabricate dental restorations. it has an indication which ranges from crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and therefore suitable for telescopic and milling work. Duo Pal 6 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. Duo Pal 6 can be veneered with suitable dental ceramics and with dental composites.
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    K Number
    K012843
    Device Name
    PORTADUR P 2, MODEL #2031
    Date Cleared
    2001-11-02

    (71 days)

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

    **WIELAND EDELMETALLE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Portadur P 2 is a gold casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/ Onlays . - Crowns . - Short span bridges . - Long span bridges . - Removable partials . and can be used for - Telescopic and milling work .
    Device Description
    Portadur P 2 is an extra-hard gold casting alloy with high contents of noble metals (75.1%), intended for dental technicians to fabricate dental restorations. lt has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. In addition, it is suitable for telescopic and milling work. Portadur P 2 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
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    K Number
    K012826
    Device Name
    BIOPORTA G, MODEL 2052
    Date Cleared
    2001-11-01

    (70 days)

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

    **WIELAND EDELMETALLE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BioPorta G is a gold-platinum ceramic 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. BioPorta G can be veneered with suitable dental ceramics as well as with dentalcomposites.
    Device Description
    BioPorta G is an extra-hard dental alloy with high contents of gold and platinum (97 %) 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 to removable partials. It is free of copper and therefore suitable for telescopic and milling work. BioPorta G 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. BioPorta G 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
    K012827
    Device Name
    PORTA AURIUM, MODEL 2067
    Date Cleared
    2001-11-01

    (70 days)

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

    **WIELAND EDELMETALLE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Porta Aurium is a universal gold-based dental 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 Aurium can be veneered with low-fusing dental ceramics with high expansion as well as with dental-composites.
    Device Description
    Porta Aurium is an extra-hard universal alloy with high contents of noble metals (80,5%), 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 to removable partials. It is free of copper and therefore suitable for telescopic and milling work. Porta Aurium 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 Aurium can be veneered with low-fusing dental ceramics with high expansion 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
    K012828
    Device Name
    PORTA SMK 82, MODEL 2032
    Date Cleared
    2001-11-01

    (70 days)

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

    **WIELAND EDELMETALLE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Porta SMK 82 is a gold-palladium ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Partial crowns, Crowns, Short span bridges, Long span bridges, Removable partials and can be used for Telescopic and milling work. Porta SMK 82 can be veneered with suitable dental ceramics as well as with dental composites.
    Device Description
    Porta SMK 82 is a gold-palladium ceramic alloy with high contents of noble metals (90.5%), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from single 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 SMK 82 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 SMK 82 can be veneered with suitable dental ceramics and with dental composites.
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    K Number
    K012831
    Device Name
    BIO PORTADUR, ORDER-NO.:2017
    Date Cleared
    2001-11-01

    (70 days)

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

    **WIELAND EDELMETALLE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BioPortadur is a gold casting 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.
    Device Description
    BioPortadur is an extra-hard gold casting alloy (96% noble metals), 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 to removable partials. In addition, it is suitable for telescopic and milling work. BioPortadur is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
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    K Number
    K012834
    Device Name
    PORTA GEO TI MODEL #2004
    Date Cleared
    2001-11-01

    (70 days)

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

    **WIELAND EDELMETALLE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Porta Geo Ti is a gold-platinum ceramic 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 Geo Ti can be veneered with suitable dental ceramics as well as with dentalcomposites.
    Device Description
    Porta Geo Ti is an extra-hard gold-platinum ceramic alloy with a high content of noble metals (95,4%), intended for dental technicians to fabricate dental restorations. lt 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 Geo Ti 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 Geo Ti 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
    K012835
    Device Name
    PORTA MAXIMUM, MODEL# 2066
    Date Cleared
    2001-11-01

    (70 days)

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

    **WIELAND EDELMETALLE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Porta Maximum is a universal gold-based dental 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 Maximum can be veneered with low-fusing dental ceramics with high expansion as well as with dental-composites.
    Device Description
    Porta Maximum is an extra-hard universal alloy with high contents of noble metals (83%), intended for dental technicians to fabricate dental restorations. lt 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 Maximum 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 Maximum can be veneered with low-fusing dental ceramics with high expansion 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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