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

    COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS

    K Number: K900799 · Decision May 15, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    2
    Review Days
    84

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    Basic Information

    Device Name
    COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS
    K Number
    K900799
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Comfort Acrylics Co.
    Date Received
    February 20, 1990
    Decision Date
    May 15, 1990
    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 Comfort Acrylics Co.

    K Number Device Name
    K910795 COMFOR-DENT DENTURE LINER