LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K100250
    Device Name
    XCERAM
    Manufacturer
    XCERAMUSA
    Date Cleared
    2010-04-08

    (71 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    XCERAMUSA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used in the manufacture of dental prosthetics: crowns, bridges, inlays, and onlays.
    Device Description
    Xceram® is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics
    Ask a Question

    Page 1 of 1