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

    SYSTEM 80 FACEPLATE-IN-THE-EAR #F1

    K Number: K822411 · Decision Jul 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    3
    Applicant Total
    6
    Review Days
    336

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    Basic Information

    Device Name
    SYSTEM 80 FACEPLATE-IN-THE-EAR #F1
    K Number
    K822411
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Western Advanced Technology, Inc.
    Date Received
    August 10, 1982
    Decision Date
    July 12, 1983
    Product Code
    EIB
    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
    EIB Syringe, Irrigating (Dental)

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