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510(k) Data Aggregation

    K Number
    K093975
    Device Name
    SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009
    Manufacturer
    Date Cleared
    2010-06-04

    (162 days)

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

    PAN GLOBAL IMPLANT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Simpler Toadstool Abutment consists of a pre-manufactured flattened ball which is directly screwed into a Simpler endosseous dental implant. The design allows for a lower profile height for a soft tissue supported overdenture. The prosthetic device is indicated for retention of soft tissue supported overdentures only and NOT for implant supported prostheses such as crowns and bridges.
    Device Description
    The Toadstool abutment is a restorative prosthesis that threads into an already integrated dental implant. A rubber O ring snaps into a metal keeper, both of which are imbedded into a denture base. When in use, this rubber ring/keeper combination attaches the denture to the abutment preventing the movement of the denture while providing a cushioning affect to the implant. It has a flattened ball at the top giving the retention area an ovoid appearance in profile. The external hexagonal portion of the abutment that allows the abutment to be torqued into the implant has been moved from below the ball at gingival level to the be part of the ovoid retention portion
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    K Number
    K092674
    Device Name
    SIMPLER TOADSTOOL MINI IMPLANT
    Manufacturer
    Date Cleared
    2009-12-28

    (118 days)

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

    PAN GLOBAL IMPLANT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Simpler Toadstool Mini Implant is intended to be used as an artificial root to provide immediate long term or transitional support for overdentures. The Simpler Toadstool Mini Implants and the Simpler HA Toadstool Mini Implants are intended to provide long term intra-bony applications for Soft Tissue Supported Over Dentures only. They are designed for immediate loading when there is good primary stability and an appropriate occlusal load. These implants may also be used for temporary soft tissue overdenture support for partial and fully edentulous restoration in the mandible and maxilla. They may be used as a minimally invasive surgical technique option for full or partial edentuloism as an alternative to more invasive surgery involving conventional implants.
    Device Description
    The Simpler Toadstool Minis and the Simpler HA Toadstool Minis are Narrow Diameter implants. They are manufactured using 6/4 Titanium alloy 90% titanium 6% aluminum and 4% vanadium for strength. All implants are arit blasted and also acid etched and are available uncoated or coated with hydroxylapatite only on the threaded part of the implant. The diameter is 2.5mm and the lenaths are 10mm. 13mm, 15 mm and 18 mm in both the coated and uncoated implants. The implants are designed as one piece with a flattened toadstool shaped abutment with a hexagonal outline at the top of the implant. The flattened, hex ball fits into a keeper with a rubber o-ring placed in the prosthesis to reduce loading and to help with retention.
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