Submission Details
| 510(k) Number | DEN230035 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 04, 2023 |
| Decision Date | May 17, 2024 |
| Days to Decision | 379 days |
| Submission Type | Direct |
| Review Panel | Dental (DE) |
| Summary | - |
Not Cleared
Direct
DEN230035 - DentalMonitoring (FDA 510(k) Clearance)
May 2024
Decision
379d
Days
Class 2
Risk
DEN230035 is an FDA 510(k) submission for the DentalMonitoring. This device is classified as a Dental Image Analyzer (Class II - Special Controls, product code SBC).
Submitted by Dental Monitoring Sas (Paris, FR). The FDA issued a Not Cleared (DENG) decision on May 17, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1770. A Dental Image Analyzer Is A Prescription Home Use Device That Uses Software Intended To Collect And Analyze Patient-specific, Optical Camera-based, Intraoral Images. The Analyses Are Provided To Dental Health Care Professionals As An Aid To Diagnosis Of Oral Health Conditions And/or To Monitor Treatment Progress..
Device Classification
| Product Code | SBC - Dental Image Analyzer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1770 |
| Definition | A Dental Image Analyzer Is A Prescription Home Use Device That Uses Software Intended To Collect And Analyze Patient-specific, Optical Camera-based, Intraoral Images. The Analyses Are Provided To Dental Health Care Professionals As An Aid To Diagnosis Of Oral Health Conditions And/or To Monitor Treatment Progress. |