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

    INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH

    K Number: K854765 · Decision Jun 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    198

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    Basic Information

    Device Name
    INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH
    K Number
    K854765
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3285
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    C&C Systems, Inc.
    Date Received
    November 27, 1985
    Decision Date
    June 13, 1986
    Product Code
    EHP
    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
    EHP Clasp, Preformed

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