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

    MOYCO-EDTA

    K Number: K950365 · Decision Apr 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    40
    Applicant Total
    14
    Review Days
    86

    Basic Information

    Device Name
    MOYCO-EDTA
    K Number
    K950365
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    UNION BROACH, DIV. MOYCO INDUSTRIES, INC.
    Date Received
    January 31, 1995
    Decision Date
    April 27, 1995
    Product Code
    KJJ
    Advisory Committee
    Unknown
    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
    KJJ Cleanser, Root Canal

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    Other Clearances by UNION BROACH, DIV. MOYCO INDUSTRIES, INC.

    K Number Device Name
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    K941574 RETRO MIRROR
    K940260 THERMAL PULP TESTER
    K935542 NICKEL-TITANIUM K-TYPE FILE
    K931742 INJECT-R FILL
    K923661 QUADRASORB FILTER
    K895174 UNION BROACH BLEACHING LIGHT
    K855136 FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE
    K852474 UNION BROACH BLEACHING LIGHT
    K823489 ENDODONTIC BROACH-BARBED BROACH
    Search all 14 clearances from UNION BROACH, DIV. MOYCO INDUSTRIES, INC. →