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

    3M UNITEK LAVA CHAIRSIDE ORAL SCANNER

    K Number: K081961 · Decision Sep 5, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    58

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    Basic Information

    Device Name
    3M UNITEK LAVA CHAIRSIDE ORAL SCANNER
    K Number
    K081961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3661
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brontes Technologies
    Date Received
    July 9, 2008
    Decision Date
    September 5, 2008
    Product Code
    NOF
    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
    NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

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    Other Clearances by Brontes Technologies

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