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510(k) Data Aggregation

    K Number
    K032750
    Device Name
    MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE
    Manufacturer
    FRIANDENT GMBH
    Date Cleared
    2003-10-02

    (27 days)

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

    FRIANDENT GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XiVE® 3.0 Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26.
    Device Description
    The XiVE® 3.0 Dental Implant System consists of subgingival threaded dental implants with 11 - 15mm lengths. The implants are coated with the FRIADENT Surface M2.1. The XiVE® 3.0 Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single tooth and splinted tooth restorations in the anterior regions of the mouth.
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    K Number
    K030639
    Device Name
    XIVE 3.0 DENTAL IMPLANT SYSTEM
    Manufacturer
    FRIANDENT GMBH
    Date Cleared
    2003-08-12

    (165 days)

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

    FRIANDENT GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XiVE 3.0 Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26.
    Device Description
    The XiVE 3.0 Dental Implant System consists of subgingival threaded dental implants with a 3.25mm diameter and lengths of 11 -- 15mm . The implants are coated with the FRIOS Deep Profile Surface. The XiVE Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for two stage procedures for single tooth replacement in the anterior regions of the mouth.
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