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510(k) Data Aggregation

    K Number
    K052714
    Device Name
    RAVE COMPOSITE BRACKET
    Manufacturer
    FDA AGENTS
    Date Cleared
    2005-10-26

    (27 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

    Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth. The devices are for Orthodontic Use Only, on the order of an Orthodontist.

    Device Description

    Rave Composite Bracket

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device (Rave Composite Bracket) and does not contain the specific information requested about acceptance criteria and study details.

    The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It outlines regulatory requirements but does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts for ground truth establishment.
    4. Adjudication method for a test set.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
    6. Results of a standalone algorithm-only performance study.
    7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This document is primarily regulatory approval, not a scientific study report.

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