FDA device listing
Cheek Retraction Mirror,Clarima,EC-Aktiv,HR-Front,Mouth Mirrors,Optima
FDA device listing 1916259036 · Roeder Dentalinstrumente GmbH & Co. KG
Key facts
| Proprietary names | Cheek Retraction Mirror,Clarima,EC-Aktiv,HR-Front,Mouth Mirrors,Optima |
|---|---|
| Owner/operator | Roeder Dentalinstrumente GmbH & Co. KG |
| Owner/operator number | 10082190 |
| Product codes | EAX |
| Device names | EAX - Mirror, Mouth |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | ROEDER DENTALINSTRUMENTE GMBH & CO. KG |
| Establishment registrations | 3003386548 |
| FEI numbers | 3003386548 |
| 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