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    FDA 510K (K092035) BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION

    FDA 510K (K092035) BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION

    $930.77 USD
    $930.77 USD
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    Device Classification Name    Implant, Endosseous, Root-Form
    510(k) Number    K092035
    Device Name    BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION
    Applicant     BICON, LLC
    Regulation Number    872.3640
    Classification Product Code    DZE  
    Subsequent Product Code    NHA  
    Date Received    07/06/2009
    Decision Date    10/15/2009
    Decision    Substantially Equivalent (SESE)
    Regulation Medical Specialty    Dental

    Total pages: 296  
    Fully redacted pages: 36  
    Content pages: 260  

    PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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