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510(k) Data Aggregation

    K Number
    K111177
    Device Name
    JUELL HARD CURE
    Manufacturer
    Date Cleared
    2011-09-12

    (138 days)

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

    JUELL DENTAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    JuellCure Hard is intended for use as a permanent hard relining for total and partial dentures. Hard permanent total or partial relining for restoring partial and complete dentures. Lengthening denture margins.
    Device Description
    JuellCure hard is a cold-curing, hard relining material for permanently relining dentures.
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    K Number
    K111178
    Device Name
    JUELL SOFT CURE
    Manufacturer
    Date Cleared
    2011-09-12

    (138 days)

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

    JUELL DENTAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    JUELLCure Soft is intended for use as a permanent soft relining for total and partial dentures - . To relieve pressure from pressure points - To dam the palatal vibrating line ● - . In cases of flabby ridge and/or insufficient adhesion - . To cushion sharp-edged alveolar processes
    Device Description
    JuellCure Soft is a self-curing, silicone-based and permanently soft relining material for removable dentures.
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    K Number
    K110548
    Device Name
    OSI O-BALL ABUTMENT HEAD IMPLANTS
    Manufacturer
    Date Cleared
    2011-07-29

    (154 days)

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

    JUELL DENTAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OSI O-ball Abutment implant is a self-tapping titanium threaded screw indicated for long term intra-bony fixation of upper and lower dentures in edentulous cases. These devices will permit immediate splinting and ability and short-term fixation of failing crown and bridge installations, for full or partial edentulism. They can be used in the anterior regions of the maxillary and mandibular arches and are indicated for immediate loading when there is good primary stability and appropriate occlusal load.
    Device Description
    The JUELL OSI O-Ball Abutment Dental Implant is available with a gingival collar in four diameters: 3.0mm, 3.5mm, 4.0mm and 4.5mm. The JUELL OSI O-Ball Abutment Dental Implant is available in thread lengths ranging from 10mm to 18mm. The implant is manufactured from ASTM F136 Ti6Al4V. The threaded surface is blasted with particulate media to increase the surface area.
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