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

    PREFORMED DENTAL IMPRESSION TRAYS

    K Number: K850776 · Decision Mar 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    317
    Registration Numbers
    317
    Same Product Code
    15
    Applicant Total
    2
    Review Days
    20

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    Basic Information

    Device Name
    PREFORMED DENTAL IMPRESSION TRAYS
    K Number
    K850776
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6880
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    L.A.K. Ent., Inc.
    Date Received
    February 26, 1985
    Decision Date
    March 18, 1985
    Product Code
    EHY
    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
    EHY Tray, Impression, Preformed

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    Other Clearances by L.A.K. Ent., Inc.

    K Number Device Name
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