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510(k) Data Aggregation

    K Number
    K031010
    Device Name
    MIRACLE 98
    Manufacturer
    SB LUCIUS, INC.
    Date Cleared
    2003-06-25

    (86 days)

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

    SB LUCIUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MIRACLE 98 is intended for manufacturing: - Porcelain to metal fabrication of single units
    Device Description
    MIRACLE 98 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for single unit with lower fusing porcelains and indirect restorative composites. MIRACLE 98 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength, durability and color of gold.
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    K Number
    K024135
    Device Name
    AIGIS-PLUS
    Manufacturer
    SB LUCIUS, INC.
    Date Cleared
    2003-03-10

    (84 days)

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

    SB LUCIUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AIGIS-PLUS is intended for manufacturing - Inlay / Onlays … - Crowns - - Short span bridges - - Long span bridges - - Removable partials -
    Device Description
    AIGIS-PLUS is an inlay, onlay, crown and bridge alloy. This device is dependable 56% gold alloy with a high gold appearance. AIGIS-PLUS is excellent for inlays, three-quarter crowns, long and short-span bridges.
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    K Number
    K024136
    Device Name
    AIGIS-SOFT
    Manufacturer
    SB LUCIUS, INC.
    Date Cleared
    2003-03-10

    (84 days)

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

    SB LUCIUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AIGIS-SOFT is intended for manufacturing - Inlay / Onlays - - Crowns - - Short span bridges - - Long span bridges " - Removable partials -
    Device Description
    AIGIS-SOFT is an inlay, onlay, crown and bridge alloy. This device is dependable 83% gold alloy with a high gold appearance. AIGIS-SOFT is excellent for inlays, three-quarter crowns, long and short-span bridges.
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    K Number
    K024142
    Device Name
    AIGIS-SUPER
    Manufacturer
    SB LUCIUS, INC.
    Date Cleared
    2003-03-10

    (84 days)

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

    SB LUCIUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AIGIS-SUPER is intended for manufacturing - Inlay / Onlays - - Crowns - - Short span bridges - - Long span bridges - - Removable partials -
    Device Description
    AIGIS-SUPER is an inlay, onlay, crown and bridge alloy. This device is dependable 53% gold alloy with a high gold appearance. AIGIS-SUPER is excellent for inlays, three-quarter crowns, long and short-span bridges.
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    K Number
    K024143
    Device Name
    AIGIS-FINE
    Manufacturer
    SB LUCIUS, INC.
    Date Cleared
    2003-03-10

    (84 days)

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

    SB LUCIUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AIGIS-FINE is intended for manufacturing - Inlay / Onlays - - Crowns - - Short span bridges - - Long span bridges - - Removable partials -
    Device Description
    AIGIS-FINE is an inlay, onlay, crown and bridge alloy. This device is dependable 7 1% gold alloy with a high gold appearance. AIGIS-FINE is excellent for inlays, three-quarter crowns, long and short-span bridges.
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    K Number
    K024139
    Device Name
    AIGIS-INLAY
    Manufacturer
    SB LUCIUS, INC.
    Date Cleared
    2003-03-07

    (81 days)

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

    SB LUCIUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AIGIS-INLAY is intended for manufacturing - Inlay / Onlays - - Crowns - - Short span bridges - - Long span bridges - - Removable partials
    Device Description
    Dental casting alloy
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    K Number
    K024144
    Device Name
    AIGIS-PT
    Manufacturer
    SB LUCIUS, INC.
    Date Cleared
    2003-03-07

    (81 days)

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

    SB LUCIUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AIGIS-PT is intended for manufacturing - Inlay / Onlays - - Crowns - - Short span bridges - - Long span bridges - - Removable partials -
    Device Description
    AIGIS-PT is an inlay, onlay, crown and bridge alloy. This device is dependable 77% gold alloy with a high gold appearance. AIGIS-PT is excellent for inlays, three-quarter crowns, long and short-span bridges.
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    K Number
    K024145
    Device Name
    AIGIS-XO
    Manufacturer
    SB LUCIUS, INC.
    Date Cleared
    2003-03-07

    (81 days)

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

    SB LUCIUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AIGIS-XO is intended for manufacturing - Inlay / Onlays - - Crowns - - Short span bridges " - Long span bridges - - Removable partials -
    Device Description
    AIGIS-XO is an inlay, onlay, crown and bridge alloy. This device is dependable 82% gold alloy with a high gold appearance. AIGIS-XO is excellent for inlays, three-quarter crowns, long and short-span bridges.
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    K Number
    K024140
    Device Name
    AIGIS-A
    Manufacturer
    SB LUCIUS, INC.
    Date Cleared
    2003-03-06

    (80 days)

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

    SB LUCIUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AIGIS-A is intended for manufacturing - Inlay / Onlays - - Crowns - - Short span bridges - - Long span bridges - - Removable partials -
    Device Description
    AIGIS-A is an inlay, onlay, crown and bridge alloy. This device is dependable 48% gold alloy with a high gold appearance. AIGIS-A is excellent for inlays, threequarter crowns, long and short-span bridges.
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    K Number
    K024141
    Device Name
    NEO 76
    Manufacturer
    SB LUCIUS, INC.
    Date Cleared
    2003-03-06

    (80 days)

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

    SB LUCIUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NEO 76 is intended for manufacturing - Inlay / Onlays - - Crowns - - Short span bridges - - Long span bridges - - Removable partials -
    Device Description
    NEO 76 is an inlay, onlay, crown and bridge alloy. This device is dependable 76% gold alloy with a high gold appearance. NEO 76 is excellent for inlays, threequarter crowns, long and short-span bridges.
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