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510(k) Data Aggregation

    K Number
    K984340
    Device Name
    STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281
    Manufacturer
    STERNGOLD/IMPLAMED
    Date Cleared
    1999-01-08

    (35 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    STERNGOLD/IMPLAMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SternOmega Temporary Cement Automix NE is indicated for use as a temporary cement for attaching all types of temporaries, e.g. temporary crowns, bridges, and inlays.
    Device Description
    The SternOmega Temporary Cement Automix NE is an auto-mixing, non-eugenol cement indicated for the temporary bonding of crowns, bridges and inlays.
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    K Number
    K984341
    Device Name
    STERNVANTAGE VARNISH LC, MODEL 221001
    Manufacturer
    STERNGOLD/IMPLAMED
    Date Cleared
    1999-01-08

    (35 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    STERNGOLD/IMPLAMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SternVantage Varnish LC is a surface sealing and finishing material for use on polymerized composite surfaces, denture bases, and temporary crowns and bridges.
    Device Description
    The Stern Vantage Varnish LC material is a single-component, acrylate-based, light-curing surface coating material for dental applications.
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    K Number
    K983786
    Device Name
    STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION
    Manufacturer
    STERNGOLD/IMPLAMED
    Date Cleared
    1998-11-13

    (17 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    STERNGOLD/IMPLAMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterngold Implant can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures.
    Device Description
    Device consists of titanium screws, and titanium alloy prosthetics, brass and stainless steel restorative components, and stainless steel and titanium alloy surgical instruments.
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    K Number
    K982692
    Device Name
    STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC
    Manufacturer
    STERNGOLD/IMPLAMED
    Date Cleared
    1998-10-22

    (80 days)

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

    STERNGOLD/IMPLAMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SternOmega Dental Composite System is indicated for dental filling of cavities. The SternOmega Composite LC is indicated for filling of all classes of cavities. The SternOmega Compomer LC is indicated for Class V restorations, cervical abrasions and erosions, Class III restorations, and for restorations of all cavity classes including Classes I and II in deciduous teeth. The SternOmega Bonding Agent is indicated for all adhesive restorations with compomers and composites, including the SternOmega Composite LC and the SternOmega Compomer LC.
    Device Description
    The SternOmega Bonding Agent is a light-curing, one-component bonding agent for compomer and composite, which is applied to dentin and enamel. The bonding agent is self-conditioning, having the primer and bonding adhesive in one bottle. The SternOmega Composite LC is a single-paste, light-curing, radiopaque universal hybrid composite dental filling material indicated for filling all classes of cavities. It is used in conjunction with the SternOmega Bonding Agent. The SternOmega Compomer LC is a single-paste, light-curing, radiopaque dental filling material indicated for permanent filling of Class III and V cavities, and for temporary filing of Class I and II cavities. It is used in conjunction with the SternOmega Bonding Agent.
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    K Number
    K982895
    Device Name
    STERNOMEGA COMPOMER CEMENT
    Manufacturer
    STERNGOLD/IMPLAMED
    Date Cleared
    1998-10-09

    (53 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    STERNGOLD/IMPLAMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SternOmega Compomer Cement Automix is indicated for use in permanent luting of crowns, bridges, inlays and onlays and for luting ceramic crowns, inlays and veneers.
    Device Description
    The SternOmega Dental Compomer Cement is an auto-mixing, chemical cure, radiopaque cement indicated for the permanent luting of crowns, bridges, inlays and onlays. The cement contains fluoride which is released over time to provide the benefits associated with a fluoride-releasing material.
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    K Number
    K981516
    Device Name
    STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB
    Manufacturer
    STERNGOLD/IMPLAMED
    Date Cleared
    1998-05-11

    (13 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    STERNGOLD/IMPLAMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterngold ImplaMed Implant System can be used in dental implant applications for oral rehabilitation of endentulous and partially dentate patients in the maxillae and mandible. Implant retained restoration may consist of single crowns or bridges as well as complete or partial dentures.
    Device Description
    Sterngold Impla Med Hex Screw Implant, TPS and HA Coated.
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    K Number
    K962324
    Device Name
    STERNGOLD U-CPF METAL ALLOY (1067800)
    Manufacturer
    STERNGOLD/IMPLAMED
    Date Cleared
    1996-07-24

    (37 days)

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

    STERNGOLD/IMPLAMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962325
    Device Name
    QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)
    Manufacturer
    STERNGOLD/IMPLAMED
    Date Cleared
    1996-07-24

    (37 days)

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

    STERNGOLD/IMPLAMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962326
    Device Name
    STERNGOLD BIO-5 (1127210)
    Manufacturer
    STERNGOLD/IMPLAMED
    Date Cleared
    1996-07-24

    (37 days)

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

    STERNGOLD/IMPLAMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962304
    Device Name
    STERNGOLD BIO-4
    Manufacturer
    STERNGOLD/IMPLAMED
    Date Cleared
    1996-07-23

    (36 days)

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

    STERNGOLD/IMPLAMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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