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510(k) Data Aggregation
K Number
K162850Device Name
GuideMia Ortho+
Manufacturer
Date Cleared
2017-03-24
(164 days)
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
GUIDEMIA TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GuideMia Ortho+ software system 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 option (Custom metal bands, export of models, Indirect Bonding) based on 3D models 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 treatment. It can be further used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
None of the export models from the software are expected to be CAD/CAM milled.
The use of the Ortho+ system requires the users to have the necessary domain training and 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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K Number
K121466Device Name
GUIDEMIA
Manufacturer
Date Cleared
2012-05-31
(14 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
GUIDEMIA TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GuideMia system is intended as software interface to transfer DICOM images generated by CT scanners, an image segmentation system to create dental anatomies from scan images, and a preoperative software for simulating/evaluating dental implant placement and surgical treatment options.
Device Description
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