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510(k) Data Aggregation

    K Number
    K052245
    Device Name
    ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS
    Manufacturer
    LAR MFG., LLC.
    Date Cleared
    2005-09-23

    (37 days)

    Product Code
    NJM
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K042178
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LAR Manufacturing, LLC Orthodontic Ceramic Brackets are indicated for orthodontic movement of teeth.

    Device Description

    LAR Manufacturing, LLC Ceramic Brackets are available if the following prescriptions: Exceed Series Brackets Roth .018" & .022" Slot Sizes Accent Series Roth .018" & .022" Slot Sizes; Edgewise .018" & .022" Slot Sizes; Ricketts .018" Slot Size; Bio-Progressive/Hilgers .018" & .022" Slot Sizes The Exceed Series and Accent Series Ceramic Brackets are produced using Al2O3, translucent polycrystalline aluminum oxide (99.9%). These Ceramic Brackets are bonded to the teeth with commercially available materials and linked together by "archwire" that applies steady, gentle pressure to produce desired tooth movement.

    AI/ML Overview

    This 510(k) premarket notification is for orthodontic ceramic brackets and does not describe software or AI. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies related to AI performance.

    The submission focuses on demonstrating "substantial equivalence" to a predicate device (Mystic Orthodontic Ceramic Brackets, K042178), primarily through material composition and intended use.

    Here's why the requested information cannot be extracted from this document:

    • No AI/Software Component: The device is a physical, non-digital orthodontic bracket. The concepts of acceptance criteria for AI performance (like sensitivity, specificity, AUC), training/test sets, ground truth, or multi-reader studies are not applicable.
    • Substantial Equivalence Pathway: 510(k) submissions, especially for devices like this, typically rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics (materials, dimensions, manufacturing processes) and intended use, rather than conducting new clinical performance studies that would generate the kind of data you're asking for.

    If this were a 510(k) for a medical device software with an AI component, the document would contain sections detailing performance metrics, validation studies, and possibly human-in-the-loop evaluations. This particular document however, does not.

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