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510(k) Data Aggregation

    K Number
    K083141
    Device Name
    SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM
    Manufacturer
    Date Cleared
    2008-11-07

    (15 days)

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

    SIMPACT LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework. The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket. The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications.
    Device Description
    The SIMPACT Endosseous Dental Implant System, Line Extension
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    K Number
    K081226
    Device Name
    SIMPACT IMPLANT SYSTEM
    Manufacturer
    Date Cleared
    2008-09-12

    (135 days)

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

    SIMPACT LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework. The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket. The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications.
    Device Description
    The SIMPACT Endosseous Dental Implant System. The Simpact implant is a threaded/tapered internal connection implant.
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