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

    DENTAL ORAL CARE SYSTEMS & COMPONENTS

    K Number: K844480 · Decision Jun 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    212

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    Basic Information

    Device Name
    DENTAL ORAL CARE SYSTEMS & COMPONENTS
    K Number
    K844480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Advanced Bio Systems, Inc.
    Date Received
    November 19, 1984
    Decision Date
    June 19, 1985
    Product Code
    EBO
    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
    EBO Denture Repair Kit

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    Other Clearances by Advanced Bio Systems, Inc.

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