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

    B&L L-BETA, MODEL WL-B1

    K Number: K060347 · Decision Jun 5, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    115

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    Basic Information

    Device Name
    B&L L-BETA, MODEL WL-B1
    K Number
    K060347
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B&L Biotech Co., Ltd.
    Date Received
    February 10, 2006
    Decision Date
    June 5, 2006
    Product Code
    EKR
    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
    EKR Plugger, Root Canal, Endodontic

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