BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING

    K Number: K922673 · Decision Feb 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    631

    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
    FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING
    K Number
    K922673
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3890
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Glasspan, Inc.
    Date Received
    June 4, 1992
    Decision Date
    February 25, 1994
    Product Code
    ELS
    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
    ELS Splint, Endodontic Stabilizing

    Similar 510(k) Clearances

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

    SPLINT IT

    FDA 510(k)
    FDA Class 2 ·Dental

    MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDIX RADICULAR BIOCERAMIC PIN

    FDA 510(k)
    FDA Class 2 ·Dental

    JACOB WIRZ TRANSFIXATION PIN

    FDA 510(k)
    FDA Class 2 ·Dental

    ZEST ENDODONTIC STABILIZER

    FDA 510(k)
    FDA Class 2 ·Dental
    View all