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

    ROOT CANAL REAMERS, TYPE K

    K Number: K822620 · Decision Sep 28, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    5
    Applicant Total
    14
    Review Days
    29

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    Basic Information

    Device Name
    ROOT CANAL REAMERS, TYPE K
    K Number
    K822620
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Union Broach, Div. Moyco Industries, Inc.
    Date Received
    August 30, 1982
    Decision Date
    September 28, 1982
    Product Code
    EKP
    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
    EKP Reamer, Pulp Canal, Endodontic

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    ROOT CANAL FILES & REAMERS

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    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
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