510(k) K212173
K212173 is an FDA 510(k) premarket notification submitted by Cdb Corporation for the device "HDH Treatment Planning System". The FDA issued a decision of Substantially Equivalent on January 25, 2022. The device falls under product code PNN (Orthodontic Software), a Class II device regulated under 21 CFR 872.5470. Cdb Corporation has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2022
- Date Received
- July 12, 2021
- 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.