LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K161256
    Device Name
    TheraCem
    Manufacturer
    BISCO, INC.
    Date Cleared
    2016-07-29

    (86 days)

    Product Code
    EMA,CLA,DAT
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K123265,K082449
    Predicate For
    K192007
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Use TheraCem to cement the following:

      1. Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal)
      1. Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia)
      1. Resin crowns, bridges, inlays and onlays (resin-based composite-ceramic hybrid)
      1. Metal (prefabricated or cast) and non-metal/fiber endodontic posts
      1. Implant supported restorations
      1. Orthodontic Appliances (brackets, bands)
    Device Description

    TheraCem is a self-etching, self-adhesive, dual-cured resin luting cement that is exclusively formulated for luting crowns, bridges, inlays, onlays and posts (prefabricated metal and nonmetal/fiber posts, as well as cast posts). TheraCem is a paste/paste, fluoride- and calciumreleasing, luting cement which requires no etching, no priming or bonding of the prepared surfaces. It is easy-to use, requires only a short chair time, and produces a good bond to most dental materials. The cement is available in a Natural shade. It is radiopaque, allowing for easy identification on radiographs.

    AI/ML Overview

    The provided text is a 510(k) summary for the dental cement TheraCem. It describes the device, its indications for use, technological characteristics, and performance data, but it does not contain the information you're looking for regarding acceptance criteria and study details for an AI/CADe device.

    Specifically, the document focuses on demonstrating substantial equivalence to predicate dental cements based on physical and mechanical properties, not on AI-assisted diagnostic or decision-making capabilities. Therefore, I cannot extract the following information from the provided text:

    1. A table of acceptance criteria and the reported device performance: The document provides a table of physical/mechanical properties tested for TheraCem and states its equivalence to predicates or compliance with ISO standards, but these are not "acceptance criteria" in the context of an AI device's diagnostic performance (e.g., sensitivity, specificity, AUC).
    2. Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic test set.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
    4. Adjudication method: Not applicable.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
    7. The type of ground truth used: For a dental cement, "ground truth" would relate to its physical properties (e.g., bond strength, setting time), which are measured according to established standards (e.g., ISO).
    8. The sample size for the training set: Not applicable, as there's no AI model being trained.
    9. How the ground truth for the training set was established: Not applicable.

    The document is for a medical device (dental cement) that does not involve AI or diagnostic imaging. The performance data presented is about the product's physical and chemical characteristics, which are compared to predicate devices for substantial equivalence.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1