BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇧🇪 Belgium

    Elemental Granulate

    K Number: K241283 · Decision Jan 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    40
    Applicant Total
    1
    Review Days
    241

    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
    Elemental Granulate
    K Number
    K241283
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zinkh NV
    Date Received
    May 7, 2024
    Decision Date
    January 3, 2025
    Product Code
    OLR
    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
    OLR Oral Wound Dressing

    Similar 510(k) Clearances

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

    Curajel™ Oral Gel

    FDA 510(k)
    FDA Unclassified ·Unknown

    MuCover (proposed name) Oral Wound Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    Dental Cone; Dental Sponge

    FDA 510(k)
    FDA Unclassified ·Unknown

    Silatrix Oral Gel

    FDA 510(k)
    FDA Unclassified ·Unknown

    HealiAid Dental Collagen Wound Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    PerioStom Dental Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all