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

    DENTAL SYRINGE SYSTEM-VARIOUS STYLES

    K Number: K832662 · Decision Oct 4, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    2
    Applicant Total
    47
    Review Days
    57

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    Basic Information

    Device Name
    DENTAL SYRINGE SYSTEM-VARIOUS STYLES
    K Number
    K832662
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3140
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Centrix, Inc.
    Date Received
    August 8, 1983
    Decision Date
    October 4, 1983
    Product Code
    KXR
    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
    KXR Applicator, Resin

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