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

    DENTAL DRESSING PLIERS

    K Number: K885219 · Decision Jan 19, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    71
    Applicant Total
    5
    Review Days
    31

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    Basic Information

    Device Name
    DENTAL DRESSING PLIERS
    K Number
    K885219
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Wen Hao, Inc.
    Date Received
    December 19, 1988
    Decision Date
    January 19, 1989
    Product Code
    EKJ
    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
    EKJ Burnisher, Operative

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    Other Clearances by Wen Hao, Inc.

    K Number Device Name
    K893027 PATIENT EXAM GLOVES (MFG JET FAR INDU. INC.)
    K893025 EXAM GLOVES (MFG. GUEY HER ENT. CO. LTD)
    K885217 DISCARD DENTAL EXPLORER
    K885218 DISCARD DENTAL MIRROR