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

    OCCLUSAL HARMONY IMPRESSION TRAY

    K Number: K884316 · Decision Dec 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    329
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    70

    Basic Information

    Device Name
    OCCLUSAL HARMONY IMPRESSION TRAY
    K Number
    K884316
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6880
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    ADVANTAGE DENTAL CO.
    Date Received
    October 13, 1988
    Decision Date
    December 22, 1988
    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

    Similar 510(k) Clearances

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

    O-TRAY IMPRESSION TRAYS

    FDA 510(k)
    FDA Class 1 ·Dental

    EOS IMPRESSION TRAYS

    FDA 510(k)
    FDA Class 1 ·Dental

    POST TRAY

    FDA 510(k)
    FDA Class 1 ·Dental

    PREFORMED DENTAL IMPRESSION TRAYS

    FDA 510(k)
    FDA Class 1 ·Dental

    CROWN INDEX TRAY

    FDA 510(k)
    FDA Class 1 ·Dental

    F-G-P TRAY

    FDA 510(k)
    FDA Class 1 ·Dental
    View all