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510(k) Data Aggregation

    K Number
    K253343

    Validate with FDA (Live)

    Device Name
    Celebrace Software
    Manufacturer
    Celebrace
    Date Cleared
    2025-12-29

    (90 days)

    Product Code
    PNN
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K233625,K232429,K203442
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Celebrace software is a software designed to assist dental professionals in planning patient treatment and designing treatment devices. The software performs simulations based on patient images, allowing reference to treatment plans, and is used as a tool to design treatment devices based on 3D mesh data. Treatment devices include orthodontic devices (orthodontic wires, orthodontic brackets and bonding trays).

    To use Celebrace Software, users must have the necessary education and domain knowledge in orthodontic practice and receive dedicated training in the use of the software.

    Device Description

    Celebrace software is a software only device that creates an orthodontic treatment plan. The input to Celebrace Software are a combination of Intraoral Scans, CBCT radiographs and patient demographics. The output of the Celebrace Software is a treatment plan, which is approved by the treating dentist, and files used for physical manufacturing of the orthodontic devices (orthodontic wires, brackets and bonding tray). The software is powered by a static algorithm that is locked at the time of release.

    AI/ML Overview

    N/A

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