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

    ALPHA-DENT CORE BUILDUP PASTE

    K Number: K932827 · Decision Sep 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    6
    Review Days
    106

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    Basic Information

    Device Name
    ALPHA-DENT CORE BUILDUP PASTE
    K Number
    K932827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alpha-Dent
    Date Received
    June 9, 1993
    Decision Date
    September 23, 1993
    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
    K904813 VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.
    K904812 COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE