BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06

    K Number: K100145 · Decision Apr 13, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    471
    Applicant Total
    1
    Review Days
    84

    Basic Information

    Device Name
    A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06
    K Number
    K100145
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    A&E BIOCERAMIC CO., LTD.
    Date Received
    January 19, 2010
    Decision Date
    April 13, 2010
    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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