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

    DIGITAL DOC

    K Number: K981663 · Decision Aug 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    281
    Applicant Total
    1
    Review Days
    91

    Basic Information

    Device Name
    DIGITAL DOC
    K Number
    K981663
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    DIGITAL DOC LLC
    Date Received
    May 11, 1998
    Decision Date
    August 10, 1998
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EIA), ordered by most recent decision date.

    Integral Dental Unit

    FDA 510(k)
    FDA Class 1 ·Dental

    Integral Dental Units

    FDA 510(k)
    FDA Class 1 ·Dental

    Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus

    FDA 510(k)
    FDA Class 1 ·Dental

    BDC Dental Unit

    FDA 510(k)
    FDA Class 1 ·Dental

    Firstar Dental Unit

    FDA 510(k)
    FDA Class 1 ·Dental

    K5

    FDA 510(k)
    FDA Class 1 ·Dental
    View all