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

    PRIMAFLOW

    K Number: K002086 · Decision Aug 17, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    205
    Registration Numbers
    205
    Same Product Code
    913
    Applicant Total
    27
    Review Days
    38

    Basic Information

    Device Name
    PRIMAFLOW
    K Number
    K002086
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DMG USA, INC.
    Date Received
    July 10, 2000
    Decision Date
    August 17, 2000
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

    Similar 510(k) Clearances

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

    Once-Fil Flow

    FDA 510(k)
    FDA Class 2 ·Dental

    EsFlow PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    BEAUTIFIL II

    FDA 510(k)
    FDA Class 2 ·Dental

    Sil-Flow

    FDA 510(k)
    FDA Class 2 ·Dental

    GrandioSO Unlimited

    FDA 510(k)
    FDA Class 2 ·Dental

    Reon

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

    Other Clearances by DMG USA, INC.

    K Number Device Name
    K160443 TempoCem Clear
    K130580 RETRACTION PASTE
    K110759 TEMPOCEM
    K102603 SA FLOWABLE ADHESIVE
    K101710 LUXATEMP ULTRA /STAR
    K100062 INFILTRATION KIT
    K093338 SELF ADHESIVE COMPOSITE LUTING CEMENT
    K093587 DENTAL MERCURY
    K081493 INFILTRATION KIT
    K080480 NANOCOMPOSITE RESTORATIVE KIT
    Search all 27 clearances from DMG USA, INC. →