510(k) K192847
K192847 is an FDA 510(k) premarket notification submitted by Diorco Co., Ltd. for the device "AUTOLIGN". The FDA issued a decision of Substantially Equivalent on July 21, 2020. The device falls under product code PNN (Orthodontic Software), a Class II device regulated under 21 CFR 872.5470.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2020
- Date Received
- October 3, 2019
- 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
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.