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510(k) Data Aggregation

    K Number
    K032448
    Device Name
    ALTATEC CERAMIC ABUTMENT
    Manufacturer
    ALTATEC BIOTECHNOLOGIES
    Date Cleared
    2003-08-22

    (14 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALTATEC BIOTECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ALTATEC BIOTECHNOLOGIES implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila. The Ti-Ceramic abutment is used with the mentioned implant supported restorations where high aesthetics are desired.
    Device Description
    ALTATEC Camlog Implant System and Abutments
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    K Number
    K022425
    Device Name
    SCREWLINE
    Manufacturer
    ALTATEC BIOTECHNOLOGIES N.A., INC.
    Date Cleared
    2002-08-14

    (21 days)

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

    ALTATEC BIOTECHNOLOGIES N

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ALTATEC BIOTECHNOLOGIES implants are indicated single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.
    Device Description
    Not Found
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    K Number
    K000065
    Device Name
    CAMLOG CYLINDER IMPLANT SYSTEM
    Manufacturer
    ALTATEC BIOTECHNOLOGIES
    Date Cleared
    2000-01-28

    (18 days)

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

    ALTATEC BIOTECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000099
    Device Name
    CAMLOG SCREW IMPLANT SYSTEM
    Manufacturer
    ALTATEC BIOTECHNOLOGIES
    Date Cleared
    2000-01-28

    (15 days)

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

    ALTATEC BIOTECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000100
    Device Name
    CAMLOG ROOTFORM IMPLANT SYSTEM
    Manufacturer
    ALTATEC BIOTECHNOLOGIES
    Date Cleared
    2000-01-28

    (15 days)

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

    ALTATEC BIOTECHNOLOGIES

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

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