BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    ULTRACAPS S

    K Number: K081273 · Decision Jul 10, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    66

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    Basic Information

    Device Name
    ULTRACAPS S
    K Number
    K081273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sdi , Ltd.
    Date Received
    May 5, 2008
    Decision Date
    July 10, 2008
    Product Code
    OIV
    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
    OIV Dental Amalgam

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    Other Clearances by Sdi , Ltd.

    K Number Device Name
    K073043 SET PP