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

    HELIOMOLAR(R) DENTAL RESTORATIVE

    K Number: K884588 · Decision Jan 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    2
    Review Days
    86

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    Basic Information

    Device Name
    HELIOMOLAR(R) DENTAL RESTORATIVE
    K Number
    K884588
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Williams Dental Co., Inc.
    Date Received
    November 2, 1988
    Decision Date
    January 27, 1989
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

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