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

    ROTARY SCALER

    K Number: K782007 · Decision Jan 3, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    5
    Review Days
    33

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    Basic Information

    Device Name
    ROTARY SCALER
    K Number
    K782007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4840
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Star Dental Mfg. Co.
    Date Received
    December 1, 1978
    Decision Date
    January 3, 1979
    Product Code
    ELB
    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
    ELB Scaler, Rotary

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