510(k) K213916
K213916 is an FDA 510(k) premarket notification submitted by Archform, Inc. for the device "ArchForm Orthodontic Software System". The FDA issued a decision of Substantially Equivalent on December 16, 2021. 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
- December 16, 2021
- Date Received
- December 15, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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.