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510(k) Data Aggregation

    K Number
    K153048
    Device Name
    AcceleDent Aura
    Manufacturer
    ORTHOACCEL TECHNOLOGIES, INC.
    Date Cleared
    2016-07-08

    (263 days)

    Product Code
    OYH
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K130643,K143120
    Why did this record match?
    Reference Devices :

    K130643,K143120

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.

    Device Description

    The AcceleDent® Aura is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent® Aura should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a modified medical device, the AcceleDent® Aura, which is an orthodontic accessory. The submission focuses on expanding the indications for use to include patients undergoing orthodontic treatment with aligners.

    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for a specific performance metric. Instead, it relies on demonstrating substantial equivalence to predicate devices, particularly regarding clinical outcomes with aligners. The key "performance" aspect is the demonstration of facilitation of tooth movement.

    Acceptance Criteria (Implied)Reported Device Performance (AcceleDent® Aura with aligners)
    Demonstrate substantial equivalence by facilitating minor anterior tooth movement during orthodontic treatment with aligners.In a retrospective cohort study, AcceleDent® Aura demonstrated a statistically significantly faster rate of tooth movement (p=0.0129) and **shorter overall treatment time (p
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