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510(k) Data Aggregation
K Number
K183695Device Name
OrthoAnalysis Software
Manufacturer
Date Cleared
2019-09-12
(255 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Inteware Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OrthoAnalysis software is designed for use as a medical device providing tools for orthodontic model design and export, inspection, analysis and treatment simulation.
The use of the OrthoAnalysis 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
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