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510(k) Data Aggregation

    K Number
    K971155
    Device Name
    MEMOREG
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    1997-05-22

    (55 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MEMOREG is indicated for bite registration in all standard situations with a stable occlusion.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental bite registration material called "Memoreg." It is not a study report and therefore does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or any details related to clinical studies.

    The letter simply states that the FDA has reviewed the manufacturer's submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    Therefore, I cannot provide the requested information based on the given text. The input does not contain a study that proves the device meets acceptance criteria.

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