CEREC Ortho Software is an AI-enabled medical device from Dentsply Sirona that the U.S. FDA cleared through 510(k) K171122 on January 11, 2018. Its lead review panel is Dental and its primary product code is PNN (Orthodontic Software).
See also all FDA AI clearances in 2018.
Key facts
| Submission number | K171122 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Dentsply Sirona |
| Lead review panel | Dental |
| Primary product code | PNN — Orthodontic Software |
| Applicant (openFDA) | Dentsply Sirona |
| Applicant location | York, PA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 872.5470 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. CEREC Ortho Software went through this pathway (K171122).
openFDA lists it as a Class 2 device under 21 CFR 872.5470. Class II devices are moderate risk and are subject to general and special controls.
Product code PNN covers 3 devices on the FDA AI list. By decision date, this device is #1 of 3 under that code. Dentsply Sirona has 2 AI-enabled devices on the list, and the Dental panel accounts for 7 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.