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510(k) Data Aggregation

    K Number
    K253565

    Validate with FDA (Live)

    Date Cleared
    2026-03-04

    (107 days)

    Product Code
    Regulation Number
    872.5470
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SureSmile Software is indicated for use as a front-end device for management of orthodontic models, systematic inspection, detailed analysis, treatment planning and simulation and the design of custom appliance systems, which may include sequential aligners, retainers, IDB trays, brackets, or wires, and dental casts. These applications are based on 3D models of the patient's dentition before the start of the orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

    The use of the SureSmile Software requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

    Device Description

    The SureSmile® Software is suitable for use for patients requiring orthodontic treatment; it allows the user to plan therapy and then order patient matched orthodontic appliances. The software includes many features to support diagnosis, planning, appliance design and treatment tracking. Additionally, SureSmile Software acts as the order management system for all SureSmile Digital Lab services and appliance production. SureSmile Software contains features to support ordering and shipment tracking. The software does not have any contact with the body.

    AI/ML Overview

    N/A

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