Manufacturer registered with FDA
Dental Hi Tec
Mazieres en Mauges, France. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 4
- 510(k) clearances
- 12025–2025
- Markets registered in
- 724 registrations outside the US
- Establishments
- 1France
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Dental Hi Tec 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 Hi Tec | 1 clearances | 2025–2025 | Below |
| Canada | Health Canada | Registration holder | DENTALHITEC | 11 | 1999–2021 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Dentalhitec | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Dental Hi Tec | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DENTALHITECDental Hi Tec | 3 | 2011–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Dentalhitec SAS | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | DENTALHITEC | 1 | 2026–2026 | 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 Hi Tec currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | QuickSleeper5Soan SleeperOne5 | 2019 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | Effitec needles | 2023 |
| Mechanical-Powered Jet InjectorEGM · Class 2 | — | Maker | QuickSleeper5 | 2025 |
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 HI TECFDA reg. 3008579121 | Mazieres en Mauges Maine-et-Loire, France | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059566). 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.