FDA device listing
UNIT, ORAL IRRIGATION
FDA device listing 1098460275 · Havenrock INC
Key facts
| Proprietary names | UNIT, ORAL IRRIGATION |
|---|---|
| Owner/operator | Havenrock INC |
| Owner/operator number | 10095003 |
| Product codes | EFS |
| Device names | EFS - Unit, Oral Irrigation |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.6510 |
| Review panels | Dental |
| Registered establishments | HAVENROCK INC |
| Establishment registrations | 3043512617 |
| FEI numbers | 3043512617 |
| 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