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510(k) Data Aggregation

    K Number
    K984248
    Device Name
    PROCEM
    Manufacturer
    ESPE DENTAL AG
    Date Cleared
    1999-01-08

    (42 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K842994,K771451,K950203,K960547
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Provisional dental cement for the temporary fixation of:

    • temporary crowns and bridges
    • temporary inlays and onlays
    • definite restorations
    Device Description

    PROCEM® is classified as a dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275) because it is a eugenol-free dental cement intended to be used for temporary fixations of crowns, bridges, inlays, and onlays.

    AI/ML Overview

    This looks like a 510(k) premarket notification for a dental cement called PROCEM®. The document indicates that this is a traditional medical device, not an AI/ML medical device. Therefore, a study demonstrating AI/ML performance metrics such as acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies would not be relevant or present in this type of submission.

    The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, function, and chemical composition (with biocompatibility data provided for a new component).

    Therefore, I cannot provide the requested information as it is not applicable to this submission.

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