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510(k) Data Aggregation

    K Number
    K034022
    Device Name
    UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES
    Manufacturer
    Date Cleared
    2004-01-30

    (32 days)

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

    DIAMODENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UCLA Abutments and Cement-On Abutments are designed for use with commercially available dental implant systems. These abutments are straight abutments and are NOT angled abutments. The abutments will seat directly on implants and are sub-structure of prosthesis. Some abutments are used as pattern in dental laboratory to make prosthesis, such as UCLA Plastic Cylinders. All abutments have been designed specifically to be compatible and to be used with each of the following implant systems and sizes (for engineering drawings please refer to Attachment GG), | IMPLANT COMPANIES | IMPLANT SYSTEMS | IMPLANT SIZE (mm) | |--------------------|--------------------------------|-----------------------------------------------------| | Nobel Biocare | NobelPerfect<br>Replace Select | 3.5, 4.3 & 5.0mm<br>3.5, 4.3, 5.0 & 6.0mm | | Straumann | ITI | 3.5mm Shoulder Diameter<br>Narrow Neck Solid Screw | | | ITI | 4.8mm Shoulder Diameter<br>Solid Screw | | | ITI | 6.5mm Shoulder Diameter<br>Wide Neck Solid Screw | | Dentsply/ Friadent | Frialit-2<br>XIVE | 3.4, 3.8, 4.5, 5.5 & 6.5mm<br>3.4, 3.8, 4.5 & 5.5mm | | 3i | Osscotite Certain | 4.0, 5.0 & 6.0mm |
    Device Description
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    K Number
    K010619
    Device Name
    UCLA AND UNIVERSAL ABUTMENTS
    Manufacturer
    Date Cleared
    2001-09-28

    (211 days)

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

    DIAMODENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K993129
    Device Name
    UCLA/UNIVERSAL ABUTMENT
    Manufacturer
    Date Cleared
    2000-03-28

    (190 days)

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

    DIAMODENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - . Universal and UCLA Abutments are used as patterns for casting of prostheses. The prosthesis (restoration) will be fastened directly to implant by using a screw. - Impression Posts are used to register the location and position of the implants in mouth. - Implant Analogs are replicas of the implants and are mounted in stone model. - . Cement Retained Abutments are used when the abutment is being used as substructure and the crown is attached on it by using dental cement. - Temporary Abutments are used while the prostheses are being made. This abutment will be used for a short time. A resin material such as Acrylic will be attached to it directly or by cement. - Tools and Accessories, such as screwdrivers are used to screw in or tighten the screws, coping screw and housing are used to screw retain the coping on the prosthesis. Drill and reamer are used to smooth out the inner surfaces of abutments after casting. All Universal, UCLA, Cement Retained and Temporary Abutments, Implant Analogs and Impression Posts are compatible and will be used with Branemark Regular Platform (RP) implants from Nobel Biocare, which have 2.70mm external hexagon and 2mm thread. All abutments will be used for fully or partially edentulous and/or for single tooth dental prostheses.
    Device Description
    UCLA/Universal Abutments, Impression Posts, Implant Analogs, Cement Retained Abutments, Temporary Abutments, Tools, and Accessories.
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