DentalMonitoring is an AI-enabled medical device from Dental Monitoring SAS that the U.S. FDA granted through De Novo DEN230035 on May 17, 2024. Its lead review panel is Dental and its primary product code is SBC (Dental Image Analyzer).
See also all FDA AI clearances in 2024.
Key facts
| Submission number | DEN230035 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Dental Monitoring SAS |
| Lead review panel | Dental |
| Primary product code | SBC — Dental Image Analyzer |
| Applicant (openFDA) | Dental Monitoring Sas |
| Applicant location | Paris, FR |
| Device class | Class 2 |
| Regulation number | 21 CFR 872.1770 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. DentalMonitoring went through this pathway (DEN230035).
openFDA lists it as a Class 2 device under 21 CFR 872.1770. Class II devices are moderate risk and are subject to general and special controls.
Product code SBC covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Dental Monitoring SAS has 1 AI-enabled device 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.