BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AMALGAM CARRIER

    K Number: K945220 · Decision Jan 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    91
    Registration Numbers
    91
    Same Product Code
    1
    Applicant Total
    11
    Review Days
    77

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    Basic Information

    Device Name
    AMALGAM CARRIER
    K Number
    K945220
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Buffalo Dental Mfg. Co., Inc.
    Date Received
    October 26, 1994
    Decision Date
    January 11, 1995
    Product Code
    EKI
    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
    EKI Carrier, Amalgam, Operative

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