EUDAMED device
Premium Teeth Resin
EUDAMED device 00198168761953 · Formlabs Ohio Inc.
Key facts
| Primary DI | 00198168761953 |
|---|---|
| Device name | Premium Teeth Resin |
| Reference or catalog number | FLPTA301 |
| Manufacturer | Formlabs Ohio Inc. |
| Manufacturer SRN | US-MF-000002761 |
| Risk class | Class IIa |
| EMDN code | Q010699 |
| EMDN description | MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | Yes |
| Status date | Oct 15, 2024 |
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: