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

    COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE

    K Number: K904812 · Decision Feb 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    6
    Review Days
    124

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    Basic Information

    Device Name
    COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE
    K Number
    K904812
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Alpha-Dent
    Date Received
    October 25, 1990
    Decision Date
    February 26, 1991
    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

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    Other Clearances by Alpha-Dent

    K Number Device Name
    K932828 CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE
    K932829 CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PAST
    K932826 CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO
    K932827 ALPHA-DENT CORE BUILDUP PASTE
    K904813 VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.