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510(k) Data Aggregation
K Number
K250198Device Name
Laon Ortho
Manufacturer
LAON MEDI Inc.
Date Cleared
2025-04-23
(90 days)
Product Code
PNN, LLZ
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
LAON MEDI Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Laon Ortho is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3D models of the patient's dentition before the start of an orthodontic treatment.
The use of the Laon Ortho 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
Laon Ortho is a PC-based software that sets up virtual orthodontics via digital impressions. It automatically segments the crown and the gum in a simple manner and provides basic model analysis to assist digital orthodontic procedures.
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K Number
K232564Device Name
Align Studio
Manufacturer
Laon Medi Inc.
Date Cleared
2024-03-12
(201 days)
Product Code
PNN, LLZ
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Laon Medi Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Align Studio is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3Dmodels of the patient's dentition before the start of an orthodontic treatment.
The use of the Align Studio requres 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
Align Studio is a PC-based software that sets up virtual orthodontics via digital impressions. It automatically segments the crown and the gum in a simple manner and provides basic model analysis to assist digital orthodontic procedures.
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