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

    FR ROOT CANAL FILLER

    K Number: K830763 · Decision Aug 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    142
    Applicant Total
    2
    Review Days
    169

    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
    FR ROOT CANAL FILLER
    K Number
    K830763
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3820
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Shizai Corp.
    Date Received
    March 10, 1983
    Decision Date
    August 26, 1983
    Product Code
    KIF
    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
    KIF Resin, Root Canal Filling

    Similar 510(k) Clearances

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

    Any-Paste

    FDA 510(k)
    FDA Class 2 ·Dental

    ZenSeal Pro

    FDA 510(k)
    FDA Class 2 ·Dental

    Root canal repair materials (nRoot BP)

    FDA 510(k)
    FDA Class 2 ·Dental

    Well-Root PT

    FDA 510(k)
    FDA Class 2 ·Dental

    One-Fil Putty Injectable

    FDA 510(k)
    FDA Class 2 ·Dental

    MTA vpt

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

    Other Clearances by Shizai Corp.

    K Number Device Name
    K830764 FR ROOT CANAL SEALER