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510(k) Data Aggregation

    K Number
    K023742
    Device Name
    SCULPTURE PLUS NANO-HYBRID COMPOSITE
    Manufacturer
    PENTRON LABORATORY TECHNOLOGIES
    Date Cleared
    2003-01-17

    (71 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    PENTRON LABORATORY TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sculpture Plus Nano-Hybrid Composite is an indirect or direct/indirect dental restorative material. It is indicated for use, in cured form, to restore carious lesions or structural defects or lost tooth structure either by itself or in combination of metal/ceramic/polymeric substrates and conditioners such as bonding, luting, etching agents commonly used in tooth restoration. The curing can be processed using photo and/or heat curing devices. The curing can accomplished in air, under vacuum or under pressure without or with inert atmosphere.
    Device Description
    Sculpture Plus Nano-Hybrid Composite is an indirect or direct/indirect dental restorative material.
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    K Number
    K023499
    Device Name
    GOLD CORE PLUS
    Manufacturer
    PENTRON LABORATORY TECHNOLOGIES
    Date Cleared
    2003-01-13

    (87 days)

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

    PENTRON LABORATORY TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gold Core Plus is indicated for use as crowns, bridges, substrate for accepting high expansion porcelains.
    Device Description
    Not Found
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    K Number
    K023501
    Device Name
    GOLD CORE 35
    Manufacturer
    PENTRON LABORATORY TECHNOLOGIES
    Date Cleared
    2002-12-18

    (61 days)

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

    PENTRON LABORATORY TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gold Core 35 is a noble, yellow alloy to be used for inlays, onlays, single crown, bridges,. implant superstructures and substrate for low fusing, high expansion porcelains and composites. .
    Device Description
    Gold Core 35 is a noble, yellow alloy to be used for inlays, onlays, single crowns, bridges, implant superstructures and substrates for low fusing, high expansion porcelains and composites. Gold Core 35 is substantially equivalent to Gold Core 55, K993173 with the exception of a minor few elements. However, the addition of these elements does not affect safety and effectiveness.
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    K Number
    K023502
    Device Name
    JEWEL CAST PLUS
    Manufacturer
    PENTRON LABORATORY TECHNOLOGIES
    Date Cleared
    2002-12-18

    (61 days)

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

    PENTRON LABORATORY TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Jewel Cast Plus is a dental alloy that is designed for use as crowns, bridges and substrate for high expansion low fusing dental porcelains and indirect composites.
    Device Description
    Jewel Cast Plus is a dental alloy that is designed for use as crowns, bridges and substrate for high expansion low fusing dental porcelains and indirect composites. Jewel Cast Plus is substantially equivalent to Pentron Laboratory Technologies, LLC., Jewel Cast III with the exception of an element. However, addition of an element does not affect safety and effectiveness because it dramatically improves the corrosion resistance of the alloy. Also, Molybdenum has been used successfully in dental alloys for over 30 years.
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    K Number
    K020555
    Device Name
    SONATA MICRO HYBRID COMPOSITE
    Manufacturer
    PENTRON LABORATORY TECHNOLOGIES
    Date Cleared
    2002-04-22

    (61 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    PENTRON LABORATORY TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sonata Micro Hybrid Composite is a dental restorative material intended for use to restore carious lesions or structural defects in teeth in combination of conditioners such as bonding, luting, etching agents commonly used in tooth restoration.
    Device Description
    Sonata Micro Hybrid Composite is a dental restorative material intended for use to restore carious lesions or structural defects in teeth in combination of conditioners such as bonding, luting, etching agents commonly used in tooth restoration.
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