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    FDA 510(k), K010849, VERTEX ETCHANT

    FDA 510(k), K010849, VERTEX ETCHANT

    $89.00 USD
    $89.00 USD
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    510(K) Number: K010849
    Device Name: VERTEX ETCHANT
    Manufacturer: APEX DENTAL MATERIALS, INC.
    Device Classification Name: Material, Tooth Shade, Resin
    Regulation Number: 872.3690
    Classification Product Code: EBF
    Date Received: 03/21/2001
    Decision Date: 09/14/2001
    Regulation Medical Specialty: Dental

    Total pages: 15
    Fully redacted pages: 1
    Content pages: 14

    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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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