510(k) K183695
K183695 is an FDA 510(k) premarket notification submitted by Inteware Co., Ltd. for the device "OrthoAnalysis Software". The FDA issued a decision of Substantially Equivalent on Sep 12, 2019. The device falls under product code PNN (Orthodontic Software), a Class II device regulated under 21 CFR 872.5470. Inteware Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 12, 2019
- Date Received
- Dec 31, 2018
- 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.