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510(k) Data Aggregation

    K Number
    K111685
    Device Name
    IP TEMP CEMENT
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2011-09-02

    (78 days)

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

    IP Temp Cement, is temporary luting cement intended for temporary cementation of permanent restorations including crowns and bridges etc. or provisional restorations to natural teeth (intraoral hard tissue) or other materials (implant abutment etc.).

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "IP Temp Cement," a dental cement. It does not contain any information about acceptance criteria or a study demonstrating device performance in the context of an AI/algorithm-based medical device.

    The letter explicitly states it's a determination of "substantial equivalence" to legally marketed predicate devices, not an evaluation of performance against specific acceptance criteria for a novel device, especially not an AI-powered one.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text. This letter pertains to a traditional dental material, not an AI or algorithm-based device.

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