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

    CRYSTAR PORCELAIN

    K Number: K833643 · Decision Dec 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    471
    Applicant Total
    59
    Review Days
    73

    Basic Information

    Device Name
    CRYSTAR PORCELAIN
    K Number
    K833643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    SHOFU DENTAL CORP.
    Date Received
    October 17, 1983
    Decision Date
    December 29, 1983
    Product Code
    EIH
    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
    EIH Powder, Porcelain

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