Ivoclar Vivadent AG
LI-MF-000000522 · Liechtenstein · Schaan
Ivoclar Vivadent AG is registered in the European database on medical devices as a manufacturer, with 11 358 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 11 114 |
|---|---|
| Class IIb | 244 |
Among these devices, 1 are declared sterile, 3 396 implantable, 69 active.
Devices declared under this manufacturer
- Gnathostar Set of 8 LD88 2A
- IPS Ivocolor Essence 1.8g E05 copper
- IPS e.max ZirCAD PlanMill LT A3 C17/5
- Ivocryl Juego de 8 A-D SOK32 C3
- Ivostar x 6 S04 1D
- SR Ivocron Dentin 30 g 220
- SR Nexco Gingiva Opaquer 2 ml pink
- SR Orthotyp DCL 8er UN4 D3
- SR Phonares II Ant. set of 6 UB73 B3
- SR Vivodent DCL Bouche à 6 IA6 B3
- SR Vivodent S PE 6er O A11 6D
- SR Vivodent S PE set of 6 UA14 3E
Showing 12 of 11 358 declared devices.
Catalogue references include 517195, 565073, 565706, 630975, 640466, 645091.
European nomenclature codes declared: Q010699, Q01010103, P01020101, Q01020605, Q0101010201, Z12119099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Ivoclar Vivadent GmbH (DE) · FDA 3004966444 |
| Devices in EUDAMED | 11 358 |
| Country of registration | Liechtenstein |
Device-level evidence
| Devices with a numeric GTIN | 11 358 |
|---|---|
| Found in the U.S. device database | 8 551 |
| Share | 75.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | IVOCLAR VIVADENT INC. |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2021-09-01 |
Licence types: Single Device (1).
Licensed under: ZIRCAD CEMENT.
North American profile: Both markets. Ivoclar Vivadent AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 043306 0282 | supplemented | 2031-05-04 |