LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K231817
    Device Name
    AlignerFlow LC
    Manufacturer
    VOCO GmbH
    Date Cleared
    2023-12-01

    (163 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AlignerFlow LC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Retention of aligners e.g. by fabrication of aligner attachments
    • Bonding of lingual retainers
    • Occlusal build-ups
    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the AlignerFlow LC device. It indicates that the device has been found substantially equivalent to predicate devices for its stated indications for use (retention of aligners, bonding of lingual retainers, and occlusal build-ups).

    However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC studies. The letter is a regulatory clearance document, not a clinical study report or a technical performance evaluation.

    Therefore, I cannot provide the requested table and study details based on the input text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1