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

    FLUID FILLED TEETHER - GEL

    K Number: K092025 · Decision Jan 27, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    570

    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
    FLUID FILLED TEETHER - GEL
    K Number
    K092025
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.5550
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kids II
    Date Received
    July 6, 2009
    Decision Date
    January 27, 2011
    Product Code
    KKO
    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
    KKO Ring, Teething, Fluid-Filled

    Similar 510(k) Clearances

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

    WATER-FILLED TEETHER

    FDA 510(k)
    FDA Class 2 ·Dental

    WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE

    FDA 510(k)
    FDA Class 2 ·Dental

    MAM COOLER

    FDA 510(k)
    FDA Class 2 ·Dental

    MAM TWISTER

    FDA 510(k)
    FDA Class 2 ·Dental

    GEL FILLED GUM SOOTHER

    FDA 510(k)
    FDA Class 2 ·Dental

    FU HONG INDUSTRIES LIMITED SOOTHER TEETHER

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

    Other Clearances by Kids II

    K Number Device Name
    K082824 FLUID FILLED TEETHER