FDA device listing
STATCLEAN
FDA device listing 1620338811 · Dent4You AG
Key facts
| Proprietary names | STATCLEAN |
|---|---|
| Owner/operator | Dent4You AG |
| Owner/operator number | 10085014 |
| Product codes | FLG |
| Device names | FLG - Cleaner, Ultrasonic, Medical Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6150 |
| Review panels | General Hospital |
| Registered establishments | DENT4YOU AG |
| Establishment registrations | 3022516928 |
| FEI numbers | 3022516928 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database