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

    AUROFILM NP

    K Number: K003387 · Decision Jan 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    152
    Applicant Total
    67
    Review Days
    70

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    Basic Information

    Device Name
    AUROFILM NP
    K Number
    K003387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3710
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Metalor Dental USA Corp.
    Date Received
    October 31, 2000
    Decision Date
    January 9, 2001
    Product Code
    EJH
    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
    EJH Alloy, Metal, Base

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