FDA device listing
COMPOSITE PASTE,COMPOSITE PASTE GERMANY,COMPOSITE POLISHING PASTE,SHOFU COMPOSITE POLISHING PASTE
FDA device listing 1425846719 · SHOFU INC.
Key facts
| Proprietary names | COMPOSITE PASTE,COMPOSITE PASTE GERMANY,COMPOSITE POLISHING PASTE,SHOFU COMPOSITE POLISHING PASTE |
|---|---|
| Owner/operator | SHOFU INC. |
| Owner/operator number | 9056340 |
| Product codes | EJR |
| Device names | EJR - Agent, Polishing, Abrasive, Oral Cavity |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.6030 |
| Review panels | Dental |
| Registered establishments | SHOFU INC. |
| Establishment registrations | 3002808149 |
| FEI numbers | 3002808149 |
| Establishment operations | 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