510(k) K162850
K162850 is an FDA 510(k) premarket notification submitted by Guidemia Technologies, LLC for the device "GuideMia Ortho+". The FDA issued a decision of Substantially Equivalent on Mar 24, 2017. The device falls under product code PNN (Orthodontic Software), a Class II device regulated under 21 CFR 872.5470. Guidemia Technologies, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 24, 2017
- Date Received
- Oct 11, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthodontic Software
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type
- 510(k)
The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.