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

    AMALGAM DISPENSER

    K Number: K771749 · Decision Sep 28, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    13

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    Basic Information

    Device Name
    AMALGAM DISPENSER
    K Number
    K771749
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3080
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    New Dimensions IN Medicine, Inc.
    Date Received
    September 15, 1977
    Decision Date
    September 28, 1977
    Product Code
    EHE
    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
    EHE Dispenser, Mercury And/Or Alloy

    Similar 510(k) Clearances

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

    DISPENSER, MERCURY & TABLET/POWDER

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    FDA Class 1 ·Dental
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