MAUDE manufacturer profile
DENTSPLY LLC · ELW
MAUDE profile for Material, Impression
Key facts
| Manufacturer | DENTSPLY LLC |
|---|---|
| Manufacturer group | DENTSPLY LLC |
| Product code | ELW |
| Product code name | Material, Impression |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Patient-Device Incompatibility, Hypersensitivity/Allergic reaction, Reaction, Burning Sensation, Numbness, No Code Available Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1