MAUDE manufacturer profile
DENTSPLY SIRONA ORTHODONTICS INC. · KMY
MAUDE profile for Positioner, Tooth, Preformed
Key facts
| Manufacturer | DENTSPLY SIRONA ORTHODONTICS INC. |
|---|---|
| Manufacturer group | DENTSPLY SIRONA ORTHODONTICS INC. |
| Product code | KMY |
| Product code name | Positioner, Tooth, Preformed |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Problems flagged by Orca1 signal analytics
- Patient-Device Incompatibility, Tooth Fracture, Hypersensitivity/Allergic reaction, Tissue Breakdown, Laceration(s), Deformity/ Disfigurement, Discomfort, Pain 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