Dent4You AG
CH-MF-000028926 · Switzerland · Heerbrugg
Dent4You AG is registered in the European database on medical devices as a manufacturer, with 1 943 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 943 |
|---|
Most frequent device types declared: BRILLIANT Crios, BRILLIANT EverGlow, BRILLIANT NG, DIATECH Diamond Instruments, Impression Material.
Among these devices, 232 are declared implantable, 1 469 reusable, 86 active.
Authorised representative in the Union: Dent4you GmbH.
Devices declared under this manufacturer
- BRILLIANT EverGlow Opaque A3 (OA3), Syringe, 1 x 3 g
- BRILLIANT EverGlow Opaque A4 (OA4), Syringe, 100 x 4 g
- BRILLIANT NG Dentin A3.5/B3, Syringe, 10 x 4 g
- DIATECH Diamonds
- DIATECH Turbocut Diamonds
- DIATECH Z-REX Diamonds
- HySolate Non-Latex DD Green medium Child (5x5), 15 pcs
- KENDA Metals Pre-Polishers for Metals, Cup, RA, 6pcs
- KENDA Microfill Pre-Polishers for Composites, Knife, RA, 100pcs
- PRESIDENT Impression Trays AC - Upper Left/Lower Right - Quadrant - Si
- PUREflow+ A2/B2, Syringe, 2g
- Polishette Polishers for Composites and Hybrid-Ceramics, Single-Use, C
Showing 12 of 1 943 declared devices.
Catalogue references include 4003.100, 60019745, 60031900, 60032370, 60033295, C6956.
European nomenclature codes declared: Q010199, Q01010103, Q019002, Q01020104, Z12011305, Q01020502.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DENT4YOU AG (CH) · FDA 3022516928 |
| Devices in EUDAMED | 1 943 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 1 943 |
|---|---|
| Found in the U.S. device database | 1 191 |
| Share | 61.3 % |
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 AG is registered in both the United States and Canada.