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

    SMARTBURS

    K Number: K080687 · Decision Jun 20, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    264
    Registration Numbers
    264
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    101

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SMARTBURS
    K Number
    K080687
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3240
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    S.S. White Burs, Inc.
    Date Received
    March 11, 2008
    Decision Date
    June 20, 2008
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EJL), ordered by most recent decision date.

    CERADRILL

    FDA 510(k)
    FDA Class 1 ·Dental

    BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS

    FDA 510(k)
    FDA Class 1 ·Dental

    TRI HAWK BUR, FG BUR

    FDA 510(k)
    FDA Class 1 ·Dental

    MONOSTERYL

    FDA 510(k)
    FDA Class 1 ·Dental

    DENTAL OR SURGICAL BUR

    FDA 510(k)
    FDA Class 1 ·Dental

    SILICONT BUR BLOCK

    FDA 510(k)
    FDA Class 1 ·Dental
    View all