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510(k) Data Aggregation

    K Number
    K052951
    Device Name
    ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM
    Manufacturer
    INNOVA LIFE SCIENCES CORP.
    Date Cleared
    2006-01-27

    (99 days)

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

    INNOVA LIFE SCIENCES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENDOPORE Anatomic dental implants may be used as artificial root components to support a prosthesis in an edentulous or partially edentulous mandible or maxilla. ENDOPORE Anatomic dental implants are provided in three diameters, each intended for surgical placement into specific regions of the mandible and maxilla. Diameters and their corresponding regions are: 3.75 mm provided in lengths of 10, 12, and 15 mm for the anterior mandible 5.0 mm provided in lengths of 8.5, 10, 12, and 15 mm for the anterior maxilla, and 4.5 mm provided in lengths of 8.5, 10, 12, and 15 mm for both the posterior mandible and posterior maxilla. The appropriate diameter of implant corresponding to the planned placement region should be selected. In addition, as with all dental implants, appropriate preoperative buccolingual width and crestal bone height measurements of the planned site should be made to ensure that adequate alveolar bone volume is available to accommodate the diameter and length of implant selected. If bone volume is not adequate, a press-fit ENDOPORE or threaded ENTEGRA implant of appropriate diameter and length may be considered for placement.
    Device Description
    The technological characteristics of the modified Endopore® Anatomic Endosseous Dental Implant System also are identical to those of the predicates, except for the use of customized configurations to fit specific anatomic jaw locations, including the anterior mandible, anterior maxilla, posterior mandible and posterior maxilla, and the addition of concentric "steps" along the length of the implant's body. The dimensions of the Anatomic Implant System include diameters of 3.75 mm, 4.5 mm, and 5 mm and lengths of 8.5 mm, 10 mm, 12 mm, and 15 mm. These dimensions are within the range of those of the previously cleared Endopore® Endosseous Dental Implant System, with the addition of the 3.75 mm diameter and 15 mm length.
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    K Number
    K053242
    Device Name
    PITT-EASY DENTAL IMPLANT SYSTEM
    Manufacturer
    INNOVA LIFE SCIENCES CORP.
    Date Cleared
    2006-01-06

    (49 days)

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

    INNOVA LIFE SCIENCES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.
    Device Description
    The Pitt-Easy™ Dental Implant System
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    K Number
    K043190
    Device Name
    SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
    Manufacturer
    INNOVA LIFE SCIENCES CORP.
    Date Cleared
    2004-12-14

    (27 days)

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

    INNOVA LIFE SCIENCES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.
    Device Description
    The principles of operation of the modified device are identical to the previously cleared Endopore Implant System except for the attachment of abutments via an internal connection.
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    K Number
    K032140
    Device Name
    5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
    Manufacturer
    INNOVA LIFE SCIENCES CORP.
    Date Cleared
    2003-10-02

    (83 days)

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

    INNOVA LIFE SCIENCES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as an endosseous dental implant in the upper or lower jaw arches to provide support for a dental prosthesis.
    Device Description
    The device consists of the implant (root component), collar, collar retaining screw, coping, coping retaining screw, healing cap, and healing cap retaining screw. Alternatively, the overdenture abutment (with an overdenture abutment retaining screw) is available; this assembly incorporates the coping retaining screw, collar, and collar retaining screw into a combined component for attachment to the root component. All of the component parts of the Endopore Implant are fabricated from a surgical grade (ASTM F 136-9) titanium-aluminum-vanadium (TicAl;V) alloy. The bone-contacting portion of the implant component has a powder-sintered porous coating of a surgical grade titanium-aluminum-vanadium alloy. The bonccontacting portion of the implant component is a truncated conical design with tapered sides.
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