FDA device listing
Tube Extension
FDA device listing 1380390155 · DENTSPLY SIRONA INC
Key facts
| Proprietary names | Tube Extension |
|---|---|
| Owner/operator | DENTSPLY SIRONA INC |
| Owner/operator number | 2511302 |
| Product codes | EFS |
| Device names | EFS - Unit, Oral Irrigation |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.6510 |
| Review panels | Dental |
| Registered establishments | DENTSPLY IH BV, DENTSPLY SIRONA INC, SIRONA DENTAL SYSTEMS GMBH |
| Establishment registrations | 9614977, 3004884150, 3011824442 |
| FEI numbers | 3003719498, 3004884150, 3011824442 |
| Establishment operations | Complaint File Establishment, Foreign Exporter |
| 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