# K162850: GuideMia Ortho+

- Pathway: 510(k) (Traditional)
- Applicant: Guidemia Technologies, LLC
- Decided: Mar 24, 2017 after 164 days
- Product code: PNN (Orthodontic Software)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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.

Source page: https://510kreport.com/device/K162850
Methodology: https://510kreport.com/methodology