Manufacturer registered with FDA
Dental Monitoring
PARIS, France. Lists 4 dental device types with FDA across 2 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 5
- 510(k) clearances
- 12024–2024
- Markets registered in
- 413 registrations outside the US
- Establishments
- 2France, United States
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Dental Monitoring as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Dental Monitoring | 1 clearances | 2024–2024 | Below |
| European Union | EUDAMED | Registration holder | Dental Monitoring SAS | 6 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DENTAL MONITORING SAS | 5 | 2020–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DENTAL MONITORING | 2 | 2019–2020 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Dental Monitoring currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | LED Adapter | 2025 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | DM ScanBox | 2018 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | DM Cheek RetractorScanBox pro | 2016 |
| Dental Image AnalyzerSBC · Class 2 | — | Maker | DentalMonitoring | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Dental MonitoringFDA reg. 3016367529 | Austin, TX, United States | Complaint file establishment |
| DENTAL MONITORINGFDA reg. 3014166037 | PARIS Ile-de-France, France | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052763). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.