Data / Medical devices / France / Dental Hi Tec
Dental Hi Tec: FDA-registered device maker in Mazieres en Mauges Maine-et-Loire, France, 1 510(k) clearance
Dental Hi Tec is registered with the FDA (registration 3008579121) in Mazieres en Mauges Maine-et-Loire, France. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 1, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008579121
- Address
- Rue de Champs Blanc, Mazieres en Mauges Maine-et-Loire, France, 49280
- Owner or operator
- Dental Hi Tec (10059566)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 31, 2019
- Registered through
- 2026
- Brand names listed
- Effitec needles, QuickSleeper5, Soan SleeperOne5
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector, Jet, Mechanical-Powered | EGM | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Exporter to the US | accessdata.fda.gov |
| Syringe, Cartridge | EJI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 1, 2025 | K243427 | QuickSleeper 5 | EGM | Substantially Equivalent | Dentalhitec | accessdata.fda.gov |
Compare with other makers
- All makers of Injector, Jet, Mechanical-Powered
- All makers of Syringe, Cartridge
- All makers of Needle, Dental
Updated August 1, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.