FDA device listing
Amalgam Carrier 1.5mm/2mm diameter, Small/Medium SKU 13-1252,Amalgam Carrier, 2.00mm and 2.75mm, Regular/Jumbo SKU…
FDA device listing 1625707253 · Signor Seven International
Key facts
| Proprietary names | Amalgam Carrier 1.5mm/2mm diameter, Small/Medium SKU 13-1252,Amalgam Carrier, 2.00mm and 2.75mm, Regular/Jumbo SKU 13-1251,Amalgam Carrier, 2.00mm and 2.75mm, Regular/Large Double End Metal SKU 13-1254,Amalgam Carrier, 2.00mm and 3.00mm, Regular/Jumbo SKU 13-1251,Amalgam Carrier 2mm/3mm diameter, Medium/Jumbo SKU 13-1256,Amalgam Carrier, Jumbo/Jumbo SKU 13-1250,Amalgam Carriers Calcium-Hydroxide… |
|---|---|
| Owner/operator | Signor Seven International |
| Owner/operator number | 10089619 |
| Product codes | EKI |
| Device names | EKI - Carrier, Amalgam, Operative |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | SIGNOR SEVEN INTERNATIONAL |
| Establishment registrations | 3015156396 |
| FEI numbers | 3015156396 |
| 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