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510(k) Data Aggregation

    K Number
    K980922
    Device Name
    PROTEC CEM.
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    1998-04-30

    (50 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K023649
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended Use: Protec Cem is intended to be used with crowns and bridges constructed of Targis/Vectris material on conventionally prepared stumps with adequate mechanical retention. Cementation of metal or Porcelain Fused to Metal (PFM) inlays, partial crowns, crowns, bridges, as well as metal root canal posts, metal post build ups, and orthodontic bands.

    Device Description

    Protec Cem

    AI/ML Overview

    I cannot answer the question based on the provided document because the document is a 510(k) clearance letter from the FDA, and it does not contain the detailed information about acceptance criteria, study design, or performance metrics requested in the prompt. It only states that the device, Protec Cem, has been found substantially equivalent to a legally marketed predicate device. The prompt asks for specifics about acceptance criteria and study data that are not present in this regulatory correspondence.

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