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510(k) Data Aggregation

    K Number
    K192007
    Device Name
    TheraBase, TheraBase Ca
    Manufacturer
    Bisco, Inc.
    Date Cleared
    2020-03-17

    (232 days)

    Product Code
    EMA,CLA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K161256,K123265
    Why did this record match?
    Device Name :

    TheraBase, TheraBase Ca

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
      1. Metal crowns, bridges, inlays (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)
      1. Lining and basing applications under restorations
    Device Description

    TheraBase and TheraBase Ca are a self-etching, self-adhesive, dual-cured resin luting cement and base/liner that is exclusively formulated for luting crowns, bridges, inlays, onlays and posts (prefabricated metal and non-metal/fiber posts, as well as cast posts) and basing/lining under restorations. TheraBase is a paste/paste, fluoride- and calcium-releasing, luting cement and base/liner which requires no etching, no priming or bonding of the prepared surfaces. TheraBase Ca is a paste/paste, calcium-releasing, luting cement and base/liner which requires no etching, no priming or bonding of the prepared surfaces. They are easy-to use, require only a short chair time, and produce a good bond to most dental materials. The cements are available in a Natural shade. They are radiopaque, allowing for easy identification on radiographs.

    AI/ML Overview

    The document you provided is a 510(k) summary for a dental device, TheraBase / TheraBase Ca. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

    Crucially, this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm or a comparative effectiveness study with human readers.

    Instead, it presents performance data for the physical and mechanical properties of the dental cement, comparing them to established ISO standards or internal benchmarks.

    Therefore, I cannot fulfill all parts of your request as it pertains to an AI/ML device with ground truth, expert adjudication, or MRMC studies. However, I can extract the relevant information regarding the device's physical and mechanical properties and present it in your requested format.

    Here's the breakdown based on the provided document:

    1. A table of acceptance criteria and the reported device performance

    Physical / Mechanical PropertyAcceptance Criteria (from document)Reported Device Performance (TheraBase)Reported Device Performance (TheraBase Ca)
    Bond StrengthHigher than or equivalent to 6.9 MPa, and bond to all substrates (Modified ISO 29022 and Gel-Cap method)Higher than or equivalent to 6.9 MPa, and bond to all the substrates.Higher than or equivalent to 6.9 MPa, and bond to all the substrates.
    Diametral Tensile StrengthGreater than or equal to 32 MPaGreater than or equal to 32 MPa.Greater than or equal to 32 MPa.
    Film Thickness1 minute at room temperature (22±1°C)
    Setting time: 1 minute at room temperature (22±1°C)
    Setting time: 1 minute at room temperature (22±1°C)
    Setting time:
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