MAUDE manufacturer profile
DENTSPLY MAILLEFER · EKS
MAUDE profile for File, Pulp Canal, Endodontic
Key facts
| Manufacturer | DENTSPLY MAILLEFER |
|---|---|
| Manufacturer group | DENTSPLY MAILLEFER |
| Product code | EKS |
| Product code name | File, Pulp Canal, Endodontic |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Break, Device Embedded In Tissue or Plaque, No Known Impact Or Consequence To Patient, No Information, Insufficient Information, No Consequences Or Impact To Patient, Material Separation, No Clinical Signs, Symptoms or Conditions 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