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

    NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY

    K Number: K861328 · Decision Apr 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    41
    Applicant Total
    12
    Review Days
    15

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    Basic Information

    Device Name
    NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY
    K Number
    K861328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1810
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Belmont Equipment Corp.
    Date Received
    April 9, 1986
    Decision Date
    April 24, 1986
    Product Code
    EAP
    Advisory Committee
    Dental
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EAP Unit, X-Ray, Intraoral

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