Dent4you GmbH
DE-MF-000006095 · Germany · Langenau
Dent4you GmbH is registered in the European database on medical devices as a manufacturer, with 100 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 100 |
|---|
Most frequent device types declared: Articulating paper, Cotton pellets, Dental roll, Guttapercha Points, LVAC.
Among these devices, 22 are declared sterile, 49 implantable.
Devices declared under this manufacturer
- DE Healthcare Guttapercha Points ISO 45-80, 120 pc.
- DE Healthcare Guttapercha Points ISO 50, 120 pc.
- DE Healthcare Guttapercha Points conventional XXF, 100 pc.
- Maxima Guttapercha Points ISO 50, 120 pc.
- Maxima Guttapercha Points ISO 55, 120 pc.
- Maxima Guttapercha Points ISO 70, 120 pc.
- Maxima Guttapercha Points ISO 90-140, 120 pc.
- Maxima Paper Points Top color ISO 40 DB 200 pc.
- Maxima Paper Points conventional XF DB 200 pc.
- PRODONTO Guttapercha Points ISO 30, 120 pc.
- ZWR M+W select #2, 300g
- ZWR Omnident #1, 300g
Showing 12 of 100 declared devices.
Catalogue references include 0195, 900-1218EU, 900-1237EU, 900-1240EU, 900-2590EU, 900-2592EU.
European nomenclature codes declared: Q01010401, Q019004, Q01020201, Q0199, Q019001.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DENT4YOU AG (CH) · FDA 3022516928 |
| Devices in EUDAMED | 100 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 74 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DENT4YOU AG |
What it holds in Canada
| Licences on record | 11 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 7 |
| Class 3 devices | 4 |
| First licensed | 1999-07-29 |
Licence types: Device Family (9), System (2).
Licensed under: TETRIC CAD, BIOSONIC US200 ULTRASONIC SCALER, BIOSONIC SCALER INSERT, BRILLIANT EVERGLOW, BRILLIANT CRIOS, ALPEN DIAMONDS.
North American profile: Both markets. Dent4you GmbH is registered in both the United States and Canada.