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    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Acrylic Block

    K Number: K143265 · Decision Apr 14, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    2
    Review Days
    152

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    Basic Information

    Device Name
    Acrylic Block
    K Number
    K143265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sun Medical Co., Ltd.
    Date Received
    November 13, 2014
    Decision Date
    April 14, 2015
    Product Code
    EBI
    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

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    Other Clearances by Sun Medical Co., Ltd.

    K Number Device Name
    K150511 Coating Material