FDA device listing
Apical Root Elevator, Fig. 302, 3.2mm,Apical Root Elevator, Fig. 303, 3.3mm,Apical Root Elevator, Straight, Fig. 301…
FDA device listing 1571330223 · ErgoDenta ApS
Key facts
| Proprietary names | Apical Root Elevator, Fig. 302, 3.2mm,Apical Root Elevator, Fig. 303, 3.3mm,Apical Root Elevator, Straight, Fig. 301, 3.0mm,Appexo Elevator, Curved, 2.5X9mm,Appexo Elevator, Curved, 2.7X9mm,Appexo Elevator, Curved, 3X9mm,Appexo Elevator, Straight, 2.5X9mm,Appexo Elevator, Straight, 2.7X9mm,Appexo Elevator, Straight, 3X9mm,Bein Root Elevator, Straight, Fig. 1, 2.3mm,Bein Root Elevator, Straight… |
|---|---|
| Owner/operator | ErgoDenta ApS |
| Owner/operator number | 10094892 |
| Product codes | EMJ |
| Device names | EMJ - Elevator, Surgical, Dental |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | ERGODENTA APS |
| Establishment registrations | 3043047788 |
| FEI numbers | 3043047788 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler |
| 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