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510(k) Data Aggregation

    K Number
    K994012
    Device Name
    TEMPOFIT, MODEL 02693
    Manufacturer
    DETAX GMBH & CO. KG
    Date Cleared
    2000-02-16

    (82 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TEMPOFIT, MODEL 02693

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Material for making temporary crowns and bridges, self curing, fast setting, bis-acrylic-composite 2:1

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a 510(k) clearance letter from the FDA for a dental material called "Tempofit," and a statement of indications for use.

    This document does not contain any information about:

    • Acceptance criteria for a device.
    • A study that proves a device meets acceptance criteria.
    • Any of the specific details requested in your prompt (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, etc.).

    The letter is simply an FDA approval notice indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications and general controls, but not performance study details.

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