MAUDE manufacturer profile
DENTSPLY MAILLEFER · EKX
MAUDE profile for Handpiece, Direct Drive, Ac-Powered
Key facts
| Manufacturer | DENTSPLY MAILLEFER |
|---|---|
| Manufacturer group | NAKANISHI INC. |
| Product code | EKX |
| Product code name | Handpiece, Direct Drive, Ac-Powered |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Detachment of Device or Device Component, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Defective Device, Unintended Movement, No Known Impact Or Consequence To Patient, Mechanical Problem, Computer Operating System Problem 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