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    FDA 510(k), K193659, iTero Element 5D

    FDA 510(k), K193659, iTero Element 5D

    $1,054.31 USD
    $1,054.31 USD
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    510(K) Number: K193659
    Device Name: iTero Element 5D
    Manufacturer: Align Technology, Inc.
    Device Classification Name: Caries Detector, Laser Light, Transmission
    Regulation Number: 872.1745
    Classification Product Code: NTK
    Date Received: 12/30/2019
    Decision Date: 03/20/2020
    Regulation Medical Specialty: Dental

    538 pages (3,174 of 3,712 original pages are fully redacted)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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