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510(k) Data Aggregation

    K Number
    K033689
    Device Name
    OSSTELL MENTOR RFA
    Manufacturer
    INTEGRATION DIAGNOSTICS LTD
    Date Cleared
    2004-02-26

    (94 days)

    Product Code
    EKX
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRATION DIAGNOSTICS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Osstell Mentor is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region. The Osstell Mentor can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluation program. The final implant treatment decisions are the responsibility of the surgeon.
    Device Description
    The Osstell Mentor Resonance Frequency Analyzer (RFA) is an updated version of the Osstell™ (K003714), the system designed to measure dental implant stability in the oral cavity and craniofacial region. Similar to K003714, the Osstell Mentor is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The updated system involves the use of a Smartpeg (aluminum rod) attached to the dental implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement probe on the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed as the Implant Stability Quotient (ISQ). The ISQ is a measurement of the stability of the implant and is derived from the resonance frequency value obtained from the Smartpeg.
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    K Number
    K003714
    Device Name
    OSSTELL RESONANCE FREQUENCY ANALYZER
    Manufacturer
    INTEGRATION DIAGNOSTICS LTD
    Date Cleared
    2001-08-09

    (251 days)

    Product Code
    EKX
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRATION DIAGNOSTICS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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