510(k) K171122
K171122 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "CEREC Ortho Software". The FDA issued a decision of Substantially Equivalent on Jan 11, 2018. The device falls under product code PNN (Orthodontic Software), a Class II device regulated under 21 CFR 872.5470. Dentsply Sirona has 87 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 11, 2018
- Date Received
- Apr 17, 2017
- 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.