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

    DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT

    K Number: K921713 · Decision Nov 4, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    40
    Applicant Total
    1
    Review Days
    576

    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
    DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT
    K Number
    K921713
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    A and V Ent.
    Date Received
    April 7, 1992
    Decision Date
    November 4, 1993
    Product Code
    KJJ
    Advisory Committee
    Unknown
    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
    KJJ Cleanser, Root Canal

    Similar 510(k) Clearances

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

    RC-SwiftPrep

    FDA 510(k)
    FDA Unclassified ·Unknown

    Sealer Solvent

    FDA 510(k)
    FDA Unclassified ·Unknown

    EPIEN Dental Cleanser

    FDA 510(k)
    FDA Unclassified ·Unknown

    Triton

    FDA 510(k)
    FDA Unclassified ·Unknown

    V-Mix

    FDA 510(k)
    FDA Unclassified ·Unknown

    Vista Rinse, Vista Rinse Plus

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all