BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇪🇸 Spain

    BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS

    K Number: K061383 · Decision Aug 3, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    264
    Registration Numbers
    264
    Same Product Code
    26
    Applicant Total
    15
    Review Days
    77

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    Basic Information

    Device Name
    BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS
    K Number
    K061383
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3240
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B.T.I. Biotechnology Institute, Sl.
    Date Received
    May 18, 2006
    Decision Date
    August 3, 2006
    Product Code
    EJL
    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
    EJL Bur, Dental

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