MAUDE manufacturer profile
COLTENE WHALEDENT INC. · EBZ
MAUDE profile for Activator, Ultraviolet, For Polymerization
Key facts
| Manufacturer | COLTENE WHALEDENT INC. |
|---|---|
| Manufacturer group | COLTENE WHALEDENT INC. |
| Product code | EBZ |
| Product code name | Activator, Ultraviolet, For Polymerization |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Overheating of Device, Insufficient Information, Burn(s) 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