EUDAMED device
Predicta™
EUDAMED device 00810000525454 · Parkell Inc.
Key facts
| Primary DI | 00810000525454 |
|---|---|
| Trade name | Predicta™ |
| Device name | Predicta Bulk Fill |
| Reference or catalog number | S615 |
| Manufacturer | Parkell Inc. |
| Manufacturer SRN | US-MF-000003761 |
| Risk class | Class IIa |
| EMDN code | Q01010103 |
| EMDN description | DENTAL CONSERVATION COMPOSITES |
| Legislation | mdd |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Nov 18, 2022 |
At a glance
- Yes 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: