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

    SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020

    K Number: K974487 · Decision Feb 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    281
    Applicant Total
    5
    Review Days
    84

    Basic Information

    Device Name
    SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020
    K Number
    K974487
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ASI MEDICAL, INC.
    Date Received
    November 26, 1997
    Decision Date
    February 18, 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

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