FDA device listing
ticon and coron restorations
FDA device listing 1548884971 · INSTITUT STRAUMANN AG
Key facts
| Proprietary names | ticon and coron restorations |
|---|---|
| Owner/operator | INSTITUT STRAUMANN AG |
| Owner/operator number | 9005052 |
| Product codes | EJH |
| Device names | EJH - Alloy, Metal, Base |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3710 |
| Review panels | Dental |
| Registered establishments | etkon GMBH, INSTITUT STRAUMANN AG, Straumann Manufacturing, Inc. |
| Establishment registrations | 9613348, 3011221537, 3024185724 |
| FEI numbers | 3004975279, 3011221537, 3024185724 |
| Establishment operations | Contract Manufacturer, Manufacturer, 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