MAUDE manufacturer profile
PRIMA DENTAL GROUP · EJL
MAUDE profile for Bur, Dental
Key facts
| Manufacturer | PRIMA DENTAL GROUP |
|---|---|
| Manufacturer group | PRIMA DENTAL GROUP |
| Product code | EJL |
| Product code name | Bur, Dental |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Foreign Body In Patient, Break, Adverse Event Without Identified Device or Use Problem, Detachment of Device or Device Component, Insufficient Information, No Clinical Signs, Symptoms or Conditions, Laceration(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