BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AJAX DENTAL UNIT

    K Number: K132245 · Decision Sep 5, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    281
    Applicant Total
    1
    Review Days
    414

    Basic Information

    Device Name
    AJAX DENTAL UNIT
    K Number
    K132245
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PRO DENTAL SERVICES LLC.
    Date Received
    July 18, 2013
    Decision Date
    September 5, 2014
    Product Code
    EIA
    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
    EIA Unit, Operative Dental

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