BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PuRE PMMA Disc

    K Number: K172281 · Decision Oct 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    188
    Applicant Total
    2
    Review Days
    83

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    Basic Information

    Device Name
    PuRE PMMA Disc
    K Number
    K172281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quest Dental USA Corp.
    Date Received
    July 28, 2017
    Decision Date
    October 19, 2017
    Product Code
    EBG
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EBG Crown And Bridge, Temporary, Resin

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    Other Clearances by Quest Dental USA Corp.

    K Number Device Name
    K201563 PuRE PMMA Disc