FDA device listing
FINGER PLUGGER,MANI PLUGGERS,PLUGGER
FDA device listing 1280940656 · MANI, INC. (HEAD OFFICE)
Key facts
| Proprietary names | FINGER PLUGGER,MANI PLUGGERS,PLUGGER |
|---|---|
| Owner/operator | MANI, INC. (HEAD OFFICE) |
| Owner/operator number | 8030343 |
| Product codes | EKR |
| Device names | EKR - Plugger, Root Canal, Endodontic |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | Mani Hanoi Co. Ltd, MANI, INC. (HEAD OFFICE), MANI, INC. (TAKANEZAWA FACILITY) |
| Establishment registrations | 8030343, 3002692886, 3007791573 |
| FEI numbers | 1000550480, 3002692886, 3007791573 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| 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