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510(k) Data Aggregation

    K Number
    K984483
    Device Name
    A-SOFT RELINER
    Manufacturer
    S & C POLYMER GMBH
    Date Cleared
    1999-02-18

    (64 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K992001
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For relining and rebasing dentures.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the "A-Soft Reliner" device. It is a traditional medical device submission and therefore does not contain information about AI/ML acceptance criteria or studies. The letter indicates that the device is for "relining and rebasing dentures" and has been found substantially equivalent to a predicate device.

    Therefore, I cannot provide the requested information regarding AI/ML clinical studies, acceptance criteria, sample sizes, ground truth establishment, or expert details, as this information is not present in the provided text.

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