EUDAMED device
Prime-Dent
EUDAMED device 00817441022818 · Prime Dental Manufacturing
Key facts
| Primary DI | 00817441022818 |
|---|---|
| Trade name | Prime-Dent |
| Device name | Etchant Gel |
| Reference or catalog number | 008-010 |
| Manufacturer | Prime Dental Manufacturing |
| Manufacturer SRN | US-MF-000008807 |
| Risk class | Class IIa |
| EMDN code | Q01010402 |
| EMDN description | ENAMEL-DENTINAL ETCHING MATERIALS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | Yes |
| Status date | Aug 7, 2025 |
At a glance
- No Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: