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510(k) Data Aggregation
K Number
K241153Device Name
Progressive Orthodontics App
Manufacturer
Progressive Aligners Inc.
Date Cleared
2024-10-11
(168 days)
Product Code
PNN, LLZ
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Progressive Aligners Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Progressive Orthodontics App is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, which may be used for sequential aligner trays or retainers. These applications are based on 3D scans of the patient's dentition before the start of an 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 Progressive Orthodontics App 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 Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient's dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment. This is a software only device. Physical outputs such as aligners are not included in the scope of the clearance.
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