BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES

    K Number: K855111 · Decision Mar 6, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    5
    Review Days
    73

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    Basic Information

    Device Name
    DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES
    K Number
    K855111
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Pacific Union Dental, Inc.
    Date Received
    December 23, 1985
    Decision Date
    March 6, 1986
    Product Code
    ELW
    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
    ELW Material, Impression

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    Other Clearances by Pacific Union Dental, Inc.

    K Number Device Name
    K863500 STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR
    K860817 ROOT CANAL ORGANIZER
    K855113 FLOSS HOLDER (PLASTIC)
    K855112 DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS