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

    ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT

    K Number: K880562 · Decision Aug 19, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    192
    Applicant Total
    5
    Review Days
    190

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    Basic Information

    Device Name
    ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT
    K Number
    K880562
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3750
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Macrochem Corp.
    Date Received
    February 11, 1988
    Decision Date
    August 19, 1988
    Product Code
    DYH
    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
    DYH Adhesive, Bracket And Tooth Conditioner, Resin

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