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510(k) Data Aggregation

    K Number
    K981433
    Device Name
    ORTHODONTIC BRACES
    Manufacturer
    MIDWEST ORTHODONTIC MFG.
    Date Cleared
    1998-06-25

    (66 days)

    Product Code
    DYW
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BRACKET IS TO BE TEMPORARILY BONDED TO THE TOOTH BRACKET IS TO BE TEMPORARTET BORDED TO THE TEETH.

    Device Description

    PLASTIC BRACKET - ORTHODONTIC

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Orthodontic Braces," specifically a "PLASTIC BRACKET - ORTHODONTIC." It confirms that the device is substantially equivalent to legally marketed devices.

    However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth methodology, or comparative effectiveness with AI assistance.

    The document is purely a regulatory clearance notice. To answer your request, I would need additional information which is not present in the provided text.

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    K Number
    K955740
    Device Name
    GLUFLORMA
    Manufacturer
    MIDWEST ORTHODONTIC MFG.
    Date Cleared
    1996-02-08

    (55 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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