MAUDE manufacturer profile
DENTSPLY LLC · ELC
MAUDE profile for Scaler, Ultrasonic
Key facts
| Manufacturer | DENTSPLY LLC |
|---|---|
| Manufacturer group | DENTSPLY LLC |
| Product code | ELC |
| Product code name | Scaler, Ultrasonic |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Overheating of Device, No Clinical Signs, Symptoms or Conditions, Restricted Flow rate, No Consequences Or Impact To Patient, No Flow, Temperature Problem, No Known Impact Or Consequence To Patient, Insufficient Information 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